The purpose of this study is to compare the effectiveness of three different intravenous (IV) patient-controlled analgesia (PCA) regimens-Fentanyl, Tramadol, and Ibuprofen-in managing postoperative pain and respiratory performance in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). While regional blocks like Erector Spinae Plane (ESP) block provide effective early analgesia, their effect typically diminishes after 8-12 hours, leading to potential 'rebound pain.' This study specifically investigates the period following the duration of the regional block's action. The primary goal is to evaluate which IV PCA protocol better controls pain (Visual Analog Scale scores) and supports better respiratory performance (measured by incentive spirometry) during the first 72 hours post-surgery
- Patients aged 18 to 80 years.
- ASA (American Society of Anesthesiologists) Physical Status Score of I-III.
- Body Mass Index (BMI) between 18 and 35 kg/m².
- Undergoing elective thoracic surgery via Video-Assisted Thoracoscopic Surgery (VATS).
- Age below 18 or above 80 years.
- Advanced organ failure (e.g., severe hepatic or renal impairment).
- ASA physical status > III.
- History of chronic pain treatment or long-term opioid use.
Parallel
Fentanyl IV PCA
DrugPatients receive intravenous Patient-Controlled Analgesia (PCA) using a fentanyl solution (4 mcg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 0.2 μg/kg/h Demand bolus dose: 20 μg Lockout interval: 20 minutes
Tramadol IV PCA
DrugPatients receive intravenous PCA using a tramadol solution (2 mg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 10 mg/h Demand bolus dose: 10 mg Lockout interval: 20 minutes
Ibuprofen IV PCA
DrugPatients receive intravenous PCA using an ibuprofen solution (2 mg/ml), initiated at the 6th postoperative hour (or earlier if VAS \>4) and continued for 72 hours. Basal infusion rate: 20 mg/h Demand bolus dose: 10 mg Lockout interval: 20 minutes
Postoperative Pain Intensity (VAS)
Evaluation of postoperative pain levels using the Visual Analog Scale (VAS). Both static (at rest) and dynamic (during coughing) VAS scores are recorded to assess the quality of analgesia. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate worse pain.
Postoperative Maximal Inspiratory Volume (ml)
Assessment of respiratory effort and lung expansion using an incentive spirometer. Patients' maximum volume reached (ml) is recorded at each visit as a marker of pulmonary function and performance.
Rescue Analgesic Requirement
Total amount of rescue analgesics required by patients when the assigned PCA regimen is insufficient to maintain a Visual Analog Scale (VAS) score of \<4. The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate worse pain.
Length of Hospital and ICU Stay
Duration of stay in the Intensive Care Unit (ICU) and the total length of hospital stay (days) from surgery to discharge.
Incidence of Postoperative Side Effects
Recording the incidence and severity of IV PCA related side effects, including nausea, vomiting, sedation, pruritus, and respiratory depression.
Click on the lead sponsor to view all of their trials.
