Clinical trials

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Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
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Status: Not yet recruiting

ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty

This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks. The primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.

Participants needed: 120
Trial details
Age: 60-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Jun 30, 2026Locations: 2
Eligibility criteria

Age between 60 and 100 years [+4]

Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine... [+9]

Status: Recruiting

Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial

his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.

Participants needed: 198
Trial details
Age: 18-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+5]

Known hypersensitivity to dexamethasone or any component of the study medication [+6]

Status: Recruiting

Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

This study will evaluate whether tranexamic acid (TXA), a medication used to reduce bleeding, is effective and safe in children undergoing surgery for idiopathic scoliosis. Significant blood loss is common during this type of surgery and often requires blood transfusions. Participants will be randomly assigned to one of three groups: (1) TXA given as an intravenous bolus followed by continuous infusion, (2) TXA given as two intravenous bolus doses, or (3) placebo (saline). Neither the patients nor the medical team will know which treatment is given. The main goal is to compare how much blood is lost during and after surgery and whether TXA reduces the need for blood transfusions. The study will also assess safety, including the risk of side effects such as seizures or blood clots. Patients will be followed for up to 30 days after surgery.

Participants needed: 90
Trial details
Age: 10-18Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Age 10 to 18 years [+3]

Congenital or acquired coagulopathy [+5]

Status: Recruiting

SII Levels Following PENG Block in Hip Arthroplasty

This randomized controlled trial evaluates the effect of ultrasound-guided Pericapsular Nerve Group (PENG) block on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.

Participants needed: 60
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Patients with ASA classification I-III [+2]

Patients who have a history of bleeding diathesis [+7]

Status: Recruiting

PENG Block vs PENG Plus Periarticular Injection vs Periarticular Injection in Older Adults

Pain after hip surgery is common in older adults and may limit early mobilization, increase the need for opioid medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Effective postoperative pain management that preserves muscle strength and supports early rehabilitation is especially important in this population. Several analgesic strategies are currently used after hip surgery. Periarticular injection (PAI), administered by the surgeon during the procedure, is commonly used as part of standard care. The pericapsular nerve group (PENG) block is a newer ultrasound-guided regional anesthesia technique that targets the sensory nerves of the hip joint while sparing motor function. It may provide effective pain relief and facilitate early mobilization. However, it is unclear whether PENG block alone is superior to periarticular injection, and whether combining both techniques provides additional benefit. The aim of this randomized controlled clinical study is to compare three postoperative analgesic strategies in older adults undergoing hip surgery: PENG block alone, PENG block combined with periarticular injection, and periarticular injection alone. Participants will be randomly assigned to one of three study groups. The primary hypothesis is that regional anesthesia with a PENG block, either alone or combined with periarticular injection, will provide superior postoperative pain control compared with periarticular injection alone. A secondary hypothesis is that the combination of PENG block and periarticular injection will offer additional analgesic benefit compared with PENG block alone. Outcomes assessed in this study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of adverse events relevant to older adults, such as hypotension, excessive sedation, or postoperative delirium. The results of this study may help determine the most effective and practical analgesic strategy for hip surgery in older adults and support evidence-based optimization of postoperative pain management.

Participants needed: 108
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Jul 1, 2026Locations: 1
Eligibility criteria

Age 65 years or older [+4]

Patient refusal or inability to provide informed consent [+11]

Status: Not yet recruiting

SII Levels Following PENG Block in Pediatric Hip Surgery

This study is a prospective, randomized, double-blind clinical trial. Its aim is to evaluate whether adding a pericapsular nerve group (PENG) block to spinal anesthesia can reduce the inflammatory response after hip surgery in children. Hip surgery in children can cause a strong stress and inflammatory reaction, which may affect pain after surgery, the need for opioid medications, and recovery. Children aged 3 to 8 years will be randomly assigned to one of two groups: spinal anesthesia alone or spinal anesthesia combined with a PENG block. The main goal is to compare changes in the Systemic Immune-Inflammation Index (SII), a blood-based marker of inflammation, measured before surgery and 24 hours after surgery. Additional outcomes include other inflammatory markers, postoperative pain, opioid use, time to first rescue pain medication, and side effects.

Participants needed: 100
Trial details
Age: 3-8Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 26, 2026Locations: 1
Eligibility criteria

Age 3-8 years [+3]

Contraindications to spinal anesthesia or PENG block [+8]

Status: Not yet recruiting

Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery

This prospective, randomized controlled trial aims to compare the analgesic efficacy of lumbar paravertebral block (L-PVB) and lumbar erector spinae plane block (L-ESPB) in elderly patients undergoing lumbar spine surgery. Effective postoperative pain management in this population is essential due to increased susceptibility to opioid-related adverse effects. Participants aged 65 years and older will be randomly assigned to receive either bilateral L-PVB or bilateral L-ESPB in addition to standardized general anesthesia. The primary objective is to evaluate differences in postoperative opioid consumption within the first 48 hours after surgery. Secondary outcomes include pain intensity, intraoperative opioid use, time to mobilization, length of hospital stay, and incidence of opioid-related adverse events.

Participants needed: 120
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 26, 2026Locations: 1
Eligibility criteria

ge ≥65 years [+4]

Refusal to participate [+11]

Status: Recruiting

SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty

This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.

Participants needed: 60
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Patients with ASA classification I-III [+2]

Patients who have a history of bleeding diathesis [+7]

Status: Recruiting

Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery

This study will compare two regional anesthesia techniques for shoulder surgery and evaluate their effects on diaphragmatic function. The standard regional anesthesia technique for shoulder surgery is the interscalene brachial plexus block (ISB), which provides effective analgesia but is frequently associated with ipsilateral hemidiaphragmatic paresis due to phrenic nerve involvement. An alternative diaphragm-sparing strategy is the combination of a suprascapular nerve block (SSNB) and an infraclavicular brachial plexus block (ICB), which may reduce the risk of diaphragmatic dysfunction while maintaining effective analgesia for shoulder surgery. All participants will receive ultrasound-guided regional anesthesia prior to surgery and will be randomly assigned to one of two groups: Group 1: Interscalene brachial plexus block Group 2: Suprascapular nerve block combined with infraclavicular brachial plexus block The primary aim of this study is to determine whether the diaphragm-sparing technique reduces the incidence of hemidiaphragmatic paresis while providing analgesia comparable to the standard interscalene block. Diaphragmatic movement will be assessed using ultrasound before and after block placement. Secondary outcomes include postoperative pain intensity, opioid consumption, pulmonary function parameters, and block-related complications.

Participants needed: 70
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age ≥ 65 years [+4]

Allergy to local anesthetics [+7]

Status: Recruiting

Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery

This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients. All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups: perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period. This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.

Participants needed: 150
Trial details
Age: 3-16Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age 3 months to 16 years [+4]

Pre-existing neurological disease or peripheral neuropathy [+11]

Status: Recruiting

PENG Block and Delirium After Hip Arthroplasty

Postoperative delirium is a common and serious complication in older adults undergoing total hip arthroplasty, associated with prolonged hospitalization, increased morbidity, delayed rehabilitation, and long-term cognitive decline. Modifiable perioperative risk factors include uncontrolled postoperative pain, opioid consumption, impaired early mobilization, and systemic inflammatory response. The Pericapsular Nerve Group (PENG) block is a regional anesthesia technique targeting the sensory innervation of the anterior hip capsule and may provide effective analgesia while preserving motor function. Improved pain control and opioid reduction may decrease the incidence of postoperative delirium. This prospective, randomized, parallel-group controlled trial aims to evaluate whether the addition of ultrasound-guided PENG block to spinal anesthesia reduces the incidence of postoperative delirium within 72 hours after primary total hip arthroplasty in patients aged 65 years or older. Delirium will be assessed using the Confusion Assessment Method (CAM) by blinded outcome assessors. Secondary outcomes include postoperative opioid consumption, pain intensity (NRS), time to first rescue opioid, postoperative nausea and vomiting, time to mobilization, block-related adverse events, and perioperative inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and monocyte-to-lymphocyte ratio). The study will enroll 144 patients randomized 1:1 to spinal anesthesia alone or spinal anesthesia plus PENG block.

Participants needed: 180
Trial details
Age: 75-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age ≥ 75 years [+6]

Pre-existing delirium, acute psychosis, or active major psychiatric disorder [+9]

Status: Recruiting

Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults

This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery. All patients in the study will receive the PENG block using 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups: Group 1: PENG block using ropivacaine only (no additional medications). Group 2: PENG block using ropivacaine with 4 mg of dexamethasone injected near the nerves. Group 3: PENG block using ropivacaine with 25 micrograms of dexmedetomidine injected near the nerves. Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of regional anesthesia. It is not known whether adding one of these medications provides longer-lasting or better pain relief compared to using ropivacaine alone. The main purpose of this study is to determine whether the addition of dexamethasone or dexmedetomidine improves the effectiveness of the PENG block in relieving pain after hip surgery. The study will evaluate pain levels, opioid consumption, time to first rescue pain medication, need for additional analgesia, and recovery outcomes. Safety, side effects, and any block-related complications will also be monitored. The investigators hypothesize that adding either perineural dexamethasone or dexmedetomidine will result in longer and more effective pain relief compared with the standard PENG block without an adjuvant. This research may help identify the most effective form of the PENG block for older adults undergoing hip surgery and contribute to improved pain management, reduced opioid use, and better postoperative recovery.

Participants needed: 120
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age 65 years or older [+5]

Refusal or inability to provide informed consent [+11]

Status: Recruiting

PENG Block Variants With Dexamethasone and Dexmedetomidine in Older Adults

This study will compare three different versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing surgery for hip conditions. The PENG block is a regional anesthesia technique that can reduce pain after surgery and decrease the need for strong opioid pain medications. All patients in the study will receive the PENG block with 20 mL of 0.2% ropivacaine, but they will be divided into three groups based on the additional medications used: Group 1: PENG block with ropivacaine plus 4 mg of dexamethasone given intravenously. Group 2: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously. Group 3: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves. Both dexmedetomidine and dexamethasone are medications that may improve the strength and duration of nerve blocks. The main goal of this study is to determine which combination provides the best pain control after hip surgery, reduces the need for opioid medications, and improves patient comfort and recovery. We also aim to evaluate the safety and side-effects of each technique. We hypothesize that adding both dexmedetomidine and dexamethasone near the nerves will provide the longest and most effective pain relief when compared to intravenous administration alone. This trial may help identify the most effective PENG block formula for older adults undergoing hip surgery and could improve pain management, decrease complications related to opioids, and support faster recovery.

Participants needed: 120
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Age 65 years or older [+5]

Patient refusal or inability to provide informed consent [+11]

Status: Recruiting

The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

Scoliosis correction surgery in children is a complex procedure with significant risks, including postoperative pain, inflammatory response, and potential neurological complications. Effective pain control and minimizing inflammation are critical for faster recovery and improved patient outcomes. Dexamethasone is commonly used as an adjuvant in regional anesthesia due to its anti-inflammatory effects and ability to prolong analgesia. However, limited research exists on the optimal route of dexamethasone administration (intravenous vs. perineural) and the best local anesthetic concentration for pain management, inflammatory response, and neuromonitoring during surgery. This study aims to compare the effects of different dexamethasone administration routes and local anesthetic concentrations on postoperative pain, inflammation (NLR, PLR), and neuromonitoring in pediatric scoliosis surgery. Results may improve regional anesthesia protocols, enhance patient safety, and offer valuable insights for clinical practice.

Participants needed: 60
Trial details
Phase: Phase 4Age: 10-18Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

>10 and <18 years old [+1]

included infection at the site of the regional block, [+4]

Status: Not yet recruiting

Type 2 Diabetes and Pregnancy a Single-arm Interventional Study

This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments. The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg/dL). Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.

Participants needed: 20
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 22, 2026Locations: 1
Eligibility criteria

Women with diagnosed pregestational type 2 diabetes or HbA1c >6.5% in the 1st tr... [+6]

Other types of diabetes including T1D and Monogenic diabetes [+3]

Status: Not yet recruiting

Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty

The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty. The main questions this study aims to answer are: Which anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone. Participants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation. The results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.

Participants needed: 90
Trial details
Age: 60-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 13, 2026Locations: 1
Eligibility criteria

Adults aged 60 to 100 years [+3]

Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone [+6]

Status: Recruiting

PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty

The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery. The main questions it aims to answer are: Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery. Participants will: Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.

Participants needed: 90
Trial details
Phase: Phase 4Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 7, 2026Locations: 1
Eligibility criteria

Age ≥ 65 years [+3]

Allergy to study drugs (ropivacaine, dexamethasone) [+5]

Status: Recruiting

The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.

Participants needed: 90
Trial details
Phase: Phase 4Age: 3-6Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: May 11, 2026Locations: 2
Eligibility criteria

children scheduled for arm/wrist/hand surgery [+1]

infection at the site of the regional block, [+4]

Status: Recruiting

The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery

The standard procedure during general anesthesia is to monitor vital functions, including cardiovascular functions such as cardiac electrical activity, using continuous ECG recording, blood pressure measurement with a sphygmomanometer, heart rate measurement, and tissue oxygenation measurement with a pulse oximeter. These are non-invasive methods, which are often insufficient in the case of extensive procedures within the abdominal aorta. In such cases, the anesthesiologist additionally use direct blood pressure measurements and central venous pressure measurements. To perform these measurements, it is necessary to insert a cannula into an artery (usually the radial artery) and a catheter into the central veins (through the internal jugular or subclavian vein). Vascular cannulation is an invasive method and may be associated with complications such as vascular thrombosis, infection at the puncture site or catheter-related infections, pneumothorax, air embolism, cardiac arrhythmias, neuropathies, hematomas, and bleeding. At the same time, they allow for a more accurate assessment of cardiovascular function and the implementation of appropriate treatment, including the administration of large amounts of infusion fluids, vasoconstrictors, and cardiac support drugs. In the current study, the investigators will additionally use a special sensor and monitor to assess the heart's performance (cardiac output) and its response to the treatment used, optimizing and supporting the circulatory system. This monitoring requires the insertion of a catheter into a central vein and artery, which is necessary during vascular surgery procedures and does not involve any additional invasive procedures. In the postoperative period, the investigators will analyze the frequency of abnormalities in laboratory tests routinely collected after surgery and the function of the central nervous system by performing simple non-invasive cognitive function tests. The benefits of using the method of assessing the patient's response to surgery and anesthesia in presented study are related to increased safety for each patient and improved perioperative treatment for all patients undergoing surgery.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Apr 28, 2026Locations: 1
Eligibility criteria

Age ≥ 18 years [+3]

Emergency or urgent surgery [+9]

Status: Recruiting

TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children

Depression in childhood and adolescence is a serious and increasing public-health problem associated with profound short- and long-term consequences, including impaired social and educational functioning, increased risk of somatic illness and substance use, and elevated mortality from suicide. Up to half of depressive disorders beginning in youth persist into adulthood, and the COVID-19 pandemic, with its attendant social isolation, has further increased the incidence of clinically significant depressive illness in children and young adults. Despite the high burden of disease, pharmacotherapeutic guidance for pediatric depression remains limited. Selective serotonin reuptake inhibitors (SSRIs) are first-line agents, yet dosing recommendations for youth do not adequately account for major sources of variability such as developmental pharmacokinetics, body size, age, comorbid diagnoses, and pharmacogenetic differences. Fluoxetine is commonly recommended in pediatric populations largely for historical reasons, while newer SSRIs such as escitalopram and sertraline are increasingly prescribed off-label without robust comparative evidence. This randomized clinical trial evaluates therapeutic drug monitoring (TDM)-guided treatment with fluoxetine, sertraline, or escitalopram in children and adults diagnosed with Major Depressive Disorder. TDM procedures will be implemented across all randomized arms to capture drug exposure and enable dose adjustments according to predefined safety and efficacy criteria. Treatments will be initiated at the lower end of recommended pediatric doses and titrated if prespecified clinical nonresponse or tolerability thresholds are met, allowing evaluation of dose-response dynamics while prioritizing patient safety. The study combines prospective, randomized comparative effectiveness methodology with intensive pharmacokinetic/pharmacodynamic (PK/PD) assessment. Repeated plasma concentration measurements will be collected at multiple timepoints to characterize within- and between-patient PK variability for each SSRI. Standardized clinical instruments will be used longitudinally to assess depressive symptom severity, response and remission rates, time to onset of therapeutic effect, adverse events (including early activation and worsening of suicidal ideation), treatment adherence, and functional outcomes (academic performance, social functioning, and quality of life). Pharmacogenetic testing will be performed to evaluate the contribution of genetic variants (including but not limited to CYP enzymes, serotonin transporter and MAO-A related polymorphisms) to PK parameters and clinical response. Integrated population PK and PK/PD modeling will (1) quantify concentration-effect and concentration-adverse-effect relationships over time, (2) identify demographic, clinical and genetic moderators of exposure and response, (3) evaluate nonlinearity in PK (e.g., dose-dependent absorption or clearance patterns), and (4) derive evidence-based therapeutic concentration ranges and individualized dosing algorithms for pediatric practice. Secondary objectives include head-to-head comparison of efficacy, tolerability, time to response, and persistence on treatment between the three SSRIs, as well as exploratory analyses of diagnostic subtypes and comorbidities that may influence outcomes. By filling critical gaps in controlled PK/PD data for the most commonly prescribed SSRIs in youth, this trial aims to move beyond meta-analytic inference toward actionable, individualized dosing recommendations. The expected outcomes are earlier identification of atypical pharmacokinetics, safer and more effective dose optimization, reduced adverse events and early discontinuation, shortened time to symptomatic improvement, and ultimately improved functional recovery and quality of life for children and young adults with depression. The study's translational PK/PD outputs will inform clinical TDM protocols, pediatric dosing guidelines, and future precision-medicine strategies in adolescent psychopharmacology.

Participants needed: 180
Trial details
Phase: Phase 4Age: 12+Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Mar 18, 2026Locations: 1
Eligibility criteria

Male or female gender. [+4]

Pregnancy, breastfeeding, or planning pregnancy. [+4]

Status: Recruiting

Will the Use of Respiratory Quotient ''RQ'' Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?

Introduction and assumptions of the research project: Patients treated in intensive care units (ICUs) require comprehensive treatment. Nutrition is an important and integral part of this therapy. Both insufficient and excessive calorie intake are associated with poorer prognosis and increased mortality in ICU patients. Furthermore, the caloric requirements of patients in life-threatening conditions in the ICU are characterized by periods of hypo- and hypermetabolism, which, if nutrition is not optimized, expose patients to overfeeding or underfeeding. Therefore, monitoring resting energy expenditure (REE) using indirect calorimetry has become the "gold standard" in the ICU. Previous methods based on mathematical formulas for calculating REE were characterized by insufficient correlation with actual demand. Indirect calorimetry uses measured exhaled carbon dioxide and the concentration of oxygen administered. Then, taking into account patient-dependent parameters such as gender, height, and weight, it indirectly calculates energy expenditure, which corresponds to caloric demand. By dividing the volume of CO2 released by the volume of O2 absorbed, investigators can obtain the respiratory quotient (RQ). This quotient is related to the type of diet and is, for example, 0.7 for fats, 0.8 for proteins, and 1.0 for carbohydrates. Its value also changes with nutritional status. High values may suggest an excessive energy supply (relative to demand), while low values may indicate a calorie deficit. Some authors suggest that the RQ ratio could potentially be used to further optimize nutritional status. Currently, however, due to insufficient research, it is mainly used in clinical practice to assess the accuracy of recording and monitoring calorimetry. This study, is trying to assess the usefulness of RQ for optimizing nutrition in patients treated in the ICU. Methodology: Study group: This will be a randomized study with a study group and a control group in patients treated in the ICU. All patients participating in the study are patients who, at the time of qualification, are mechanically ventilated and treated in the ICU. These will be patients of both sexes, aged 18-85 years. The control group will be fed under the supervision of indirect calorimetry and REE, in accordance with current ICU nutrition guidelines. In the study group, nutritional preparations will be additionally systematized and selected for each patient depending on their RQ value, and caloric requirements will be controlled by indirect calorimetry and REE, as in the control group. Regular assessments of albumin, total protein, total cholesterol, LDL, HDL, iron, glycemia, Na+, K+, and triglycerides will be conducted, collected along with the routine test package. In addition, typical endpoints for patients treated in the ICU will be assessed, such as length of stay in the ICU, length of mechanical ventilation, number of days without a ventilator, 28-day survival, and survival to hospital discharge. Expected duration of the study: October 2024 to October 2026 (2 years) Conditions for inclusion in the study: patients \> 18 years of age, treated in the ICU, mechanically ventilated, covered by universal health insurance Conditions for exclusion from the study: ECMO therapy, the need for mechanical ventilation with an oxygen concentration in the breathing mixture FiO2 \> 60%, patients breathing independently without the aid of a ventilator, critically ill patients who are not expected to survive the next 48 hours, pregnant women, patients \< 18 years of age or \> 85 years of age Reasons for discontinuing the study: 1. if, during the course of the study, there are clear indications that one of the groups will experience or worsen final outcomes such as mortality, 28-day mortality, length of stay in the ICU - which would suggest a clear advantage of one of the chosen strategies, along with an increase in the number of patients included in the study, a regular analysis of the current effects of both strategies will be conducted, 2. the patient develops hypersensitivity/intolerance to nutritional preparations, with no possibility of switching to another preparation used in the study, Expected results and their planned subsequent use: Patients from the control group, should achieve faster stabilization of nutritional parameters and fewer episodes of underfeeding and overfeeding. This should translate into improved endpoints such as mortality, length of stay in the ICU, and shorter mechanical ventilation time. In addition, the systematization and algorithms for the use of nutritional products developed during the study can be further used in department of the study and other departments around the world.

Participants needed: 200
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Mar 9, 2026Locations: 1
Eligibility criteria

patient treated in the ICU [+2]

ECMO therapy [+4]

Status: Recruiting

PENG Block With Dexmedetomidine in Older Adults

Pain after hip surgery is a common problem in older adults and may delay early mobilization, increase the need for opioid pain medications, and contribute to complications such as delirium, nausea, or prolonged hospital stay. Regional anesthesia techniques are increasingly used to improve pain control while reducing the use of systemic opioids. The pericapsular nerve group (PENG) block is a modern ultrasound-guided regional anesthesia technique designed to provide effective pain relief after hip surgery while preserving muscle strength. It allows patients to begin mobilization earlier and may reduce the risk of postoperative complications, which is particularly important in older adults. Ropivacaine is a commonly used local anesthetic for nerve blocks. Dexmedetomidine is a medication that, when added in small doses to local anesthetics, may prolong pain relief and improve the quality of nerve blocks without significantly increasing side effects. However, the benefits and safety of adding dexmedetomidine to the PENG block in older adults have not been sufficiently studied. The aim of this randomized controlled clinical study is to compare the effectiveness and safety of two PENG block techniques in older adults undergoing hip surgery. Participants will be randomly assigned to one of two groups. One group will receive a PENG block with 20 mL of 0.2% ropivacaine. The second group will receive a PENG block with 20 mL of 0.2% ropivacaine combined with 25 micrograms of dexmedetomidine. The study hypothesis is that the addition of dexmedetomidine to ropivacaine in the PENG block will provide longer-lasting and more effective postoperative pain relief compared with ropivacaine alone, without increasing adverse effects. Outcomes assessed in the study will include postoperative pain intensity, need for additional pain medications, time to first mobilization, and the occurrence of side effects such as low blood pressure, slow heart rate, excessive sedation, or delirium. The results of this study may help optimize regional anesthesia techniques for hip surgery in older adults and contribute to safer, more effective postoperative pain management strategies.

Participants needed: 30
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Age 65 years or older [+5]

Patient refusal or inability to provide informed consent [+11]

Status: Recruiting

PENG Block vs Suprainguinal FICB vs Lumbar ESPB for Analgesia After Hip Surgery

This randomized, double-blinded, controlled clinical trial compares three motor-sparing regional anesthesia techniques used for postoperative analgesia in patients undergoing hip arthroplasty: the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB). Although all three techniques are widely used in modern hip surgery, their relative analgesic efficacy, opioid-sparing potential, and impact on early functional recovery have not been directly compared in a single study. The primary objective is to determine which block provides the most effective postoperative analgesia while preserving motor function and facilitating early mobilization. Secondary objectives include comparisons of opioid consumption, pain scores at rest and during movement, time to first rescue analgesia, block-related adverse events, quadriceps strength, incidence of postoperative nausea and vomiting, and early functional outcomes. This study aims to identify the optimal motor-sparing regional anesthesia strategy for older adults undergoing hip arthroplasty.

Participants needed: 93
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Adults aged 65 years or older scheduled to undergo elective hip arthroplasty und... [+4]

Inability to provide informed consent due to cognitive impairment, language barr... [+11]

Status: Recruiting

Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA

This randomized, double-blind, controlled trial is designed to compare the analgesic efficacy and safety of perineural dexamethasone versus perineural dexmedetomidine as adjuvants to ropivacaine for ultrasound-guided interspace between the popliteal artery and the capsule of the posterior knee (iPACK) and adductor canal blocks in patients undergoing primary unilateral total knee arthroplasty (TKA). Elderly participants scheduled for elective TKA will be randomized into three parallel groups: ropivacaine alone (control), ropivacaine combined with perineural dexamethasone, or ropivacaine combined with perineural dexmedetomidine. The primary objective is to determine whether the addition of either adjuvant reduces postoperative opioid consumption compared with ropivacaine alone and to assess potential differences in analgesic efficacy between the two adjuvants. Secondary outcomes include pain intensity at rest and during mobilization, time to first rescue analgesia, quality of early functional recovery, and the incidence of adverse events, including postoperative nausea and vomiting, motor impairment, and hemodynamic instability.

Participants needed: 96
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Feb 4, 2026Locations: 1
Eligibility criteria

Age ≥ 65 years [+3]

Contraindications to peripheral nerve blocks (infection at injection site, coagu... [+5]

Status: Recruiting

ACB With S-ESPB Versus ACB With iPACK for Knee Arthroplasty

This study will compare two regional anesthesia strategies for pain management after total knee arthroplasty in adults. Both strategies use an adductor canal block (ACB) to provide analgesia while preserving quadriceps muscle strength. The ACB is then combined with either a sacral erector spinae plane block (S-ESPB) or an iPACK (infiltration between the popliteal artery and the posterior capsule of the knee) block to improve posterior knee analgesia. All patients will receive an ultrasound-guided adductor canal block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of two groups: Group 1: ACB combined with a sacral erector spinae plane block (S-ESPB) using 20 mL of 0.2% ropivacaine. Group 2: ACB combined with an iPACK block using 20 mL of 0.2% ropivacaine. Both techniques aim to provide effective postoperative analgesia while minimizing motor blockade and allowing for early mobilization. It is not known whether combining ACB with S-ESPB or with iPACK provides superior pain control, reduces opioid requirements, or results in better functional recovery after total knee arthroplasty. The main purpose of this study is to compare the time to first rescue analgesia and overall postoperative pain control between the two regional anesthesia strategies. The study will also evaluate opioid consumption, motor function, functional mobility, side effects, and block-related complications. We hypothesize that both combinations will provide effective analgesia, but their impact on pain intensity, duration of analgesia, and functional recovery may differ.

Participants needed: 80
Trial details
Age: 65-100Biological sex: AllType: InterventionalSponsor: Poznan University of Medical SciencesUpdated: Feb 2, 2026Locations: 1
Eligibility criteria

Age 65 years or older [+5]

Refusal or inability to provide informed consent [+10]