A Prospective, Double-Blinded, Randomized Controlled Trial of Intraperitoneal Bupivacaine - Tramadol Instillation in Laparoscopic Surgery Patients

Abstract

Background: Postoperative pain after laparoscopic surgery arises from peritoneal irritation, diaphragmatic stretch, and residual CO₂. Opioid-based analgesia is effective but associated with nausea, vomiting, ileus, and delayed discharge. Multimodal analgesia, including intraperitoneal instillation of local anesthetics with tramadol, may provide synergistic analgesia. Objective: To evaluate intraperitoneal bupivacaine–tramadol versus placebo in reducing postoperative pain, PONV, and analgesic requirements in laparoscopic appendectomy and cholecystectomy. Methods: This prospective, randomized, double-blind controlled trial was conducted at GMC Jalgaon (Nov 2023–Jul 2025) including 100 ASA I–II patients aged 18–65. Patients were randomized 1:1 into study (20 ml 0.25% bupivacaine + 100 mg tramadol) and control (20 ml saline) groups. Outcomes included rescue analgesia, VAS (2–8h), PONV, and shoulder-tip pain. Results: Rescue analgesia was required in 36% vs 56% (RR=0.64, p=0.07). Mean VAS was 3.8 ± 1.2 vs 4.4 ± 1.4 (p=0.08). PONV was significantly reduced (28% vs 64%, OR=0.23, p=0.0006). Shoulder-tip pain occurred in 8% vs 24% (p=0.054). Conclusion: Intraperitoneal bupivacaine–tramadol is a safe, simple, and cost-effective adjunct that reduces PONV and trends toward better pain control, supporting integration into ERAS protocols.