Erector Spinae Plane Block for Percutaneous Nephrolithotomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFadime Tosun

About this trial

Percutaneous nephrolithotomy (PCNL) is an effective standard urological procedure for the fragmentation and removal of large renal calculi. Although PCNL is performed as a minimally invasive technique, dilation of the renal capsule and parenchymal tract, as well as peritubular distension caused by the nephrostomy tube, may result in severe postoperative pain. Various analgesic strategies have been described in the literature for postoperative pain management following PCNL. These include systemic opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and several regional analgesia techniques. However, due to their adverse effect profiles, opioids and NSAIDs are not ideal options, particularly in patients with renal dysfunction. Regional techniques that have been utilized include local infiltration, intercostal nerve blocks, paravertebral blocks, and epidural analgesia.

The kidney is primarily innervated between the T10 and L1 segments, whereas the ureter receives innervation from T10 to L2. Based on this anatomical knowledge, unilateral regional blockade between T10 and L2 can provide adequate analgesia for PCNL procedures. Thoracic paravertebral block was previously a commonly preferred technique; however, it may be associated with complications such as intravascular injection, unintended epidural or intrathecal spread, and pneumothorax during its performance. In recent years, the number of reports describing the use of the erector spinae plane block (ESPB) as part of multimodal anesthesia for postoperative analgesia has increased. In ESPB, local anesthetic is injected into the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, and has been reported to spread to multiple paravertebral spaces. ESPB is considered a peri-paravertebral block that can affect both visceral and somatic pain pathways.

The aim of this study is to evaluate the effect of ultrasound-guided erector spinae plane block on intraoperative and postoperative opioid consumption, postoperative pain scores, and quality of recovery in patients undergoing percutaneous nephrolithotomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

American Society of Anesthesiologists (ASA) physical status I-II.

Scheduled for elective percutaneous nephrolithotomy under general anesthesia.

Able to understand the study procedures and provide written informed consent.

Disqualifiers

Age < 18 years.

ASA physical status III-IV.

Refusal to participate in the study.

Known allergy or contraindication to local anesthetics (bupivacaine), opioids, or study medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Block

    Procedure/Surgery

    In addition to standard general anesthesia, patients are scheduled to undergo an ultrasound-guided erector spinae plane block at the T10 transverse process level using 20 ml of 0.25% bupivacaine

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Block groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total Postoperative Tramadol Consumption within 24 Hours

Total dose of intravenous tramadol (mg) administered as rescue analgesia during the first 24 hours after surgery.

Time frame
0-24 hours postoperatively

Secondary outcomes

1

Intraoperative Remifentanil Consumption

Total dose of remifentanil (µg) used intraoperatively

Time frame
İntraoperative period
2

Postoperative Pain Scores (NRS)

Postoperative pain scores will be assesed with numerical pain scores at postoperative period. NRS score will range to 0-10. O refers to no pain and 10 refers to the worst pain ever had.

Time frame
Postoperative 0th, 2nd, 4th, 6th, 12th and 24th hours
3

QoR-15T (Turkish) quality of recovery scale

The Quality of Recovery-15 (QoR-15) at 24 hours scale is a patient-reported outcome questionnaire that measures the quality of postoperative recovery. The validity of Quality of Recovery-15 (QoR-15) has been proven in many languages. In our study, the Turkish Quality of Recovery-15 (QoR-15T) will be used to measure postoperative recovery in the Turkish population. The Turkish Quality of Recovery-15 (QoR-15T) scale consists of 2 parts and a total of 15 questions are asked to patients. Patients can score each question between 0 and 10, so the total Turkish Quality of Recovery-15 (QoR-15T) score can range from 0 to 150. A higher score indicates a better recovery quality.

Time frame
Postoperative 24th hours, based on a single assessment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fadime Tosun

Lead sponsor

Adiyaman University

Sponsor institution

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