Programmed Intermittent Epidural Bolus for Postoperative Pain Control After Laparotomy: Finding the Best Dose by Gender Using a Sequential Allocation Method

What this Trial Is About

Researchers are evaluating the optimal volume dose of programmed intermittent epidural bolus (PIEB) using bupivacaine combined with fentanyl and adrenaline for pain control after open abdominal surgery via a large midline laparotomy incision. The study aims to determine the effective PIEB volume that provides successful analgesia in 90% of patients on the first postoperative day, separately for men and women, due to possible sex-based differences in pain control needs. This is a randomized, triple-blind trial involving adult patients undergoing elective surgery requiring a large incision. Participants will receive programmed intermittent epidural boluses of bupivacaine 0.05% with fentanyl 2 mcg/mL and adrenaline 2 mcg/mL at fixed 60-minute intervals, with bolus volumes ranging from 5 to 10 mL depending on group allocation. Patients can also use patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 30 minutes as needed for pain above 4 out of 10. The epidural catheter is placed before surgery and the infusion begins after an initial intraoperative bolus. The study medication and management protocol will be used for 36 hours post-surgery. During the study, participants will be assessed for pain control success, motor block, hypotension, sensory block level, patient satisfaction, and quality of recovery using standardized scales and questionnaires at 24 and 48 hours after surgery. Data on surgery length, opioid and local anesthetic doses, and adverse events will be collected. The primary outcome is successful analgesia defined by limited patient-controlled bolus use on the first postoperative day. Monitoring includes sensory testing and adherence to pain management protocols until the end of the study period.

PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose