SP1.2.9To Evaluate the Analgesic Efficacy of Intraperitoneal Tramadol Vs Placebo for Post Operative Pain Relief Following Laparoscopic Cholecystectomy, A Double Blind Randomized Control Trial

Abstract

Abstract Aim To study the effectiveness of intraperitoneal instillation of tramadol for postoperative laparoscopic cholecystectomy (LC) pain relief and improve incidence of adverse effect. Methods Double blinded randomized controlled trial over 1 year. The Ethical Clearance was obtained from Institutional Ethics Committee. 60 patients scheduled for LC were enrolled in the study. Patients were randomly assigned into 2 groups using computer generated random numbers. Group T: Received intraperitoneal tramadol 100 mg (diluted in 20 mls distilled water). Group S: Received 20 ml of intraperitoneal normal saline. Pain was assessed using VAS. The assessment was done at 0, 15, 30, 60 minutes, 4, 8, 12, 16 and 24 hours. Incidence of adverse effect were observed. Results In group T, the mean pain scores at all the intervals were significantly low (p < 0.050) except at 24 hours (p = 0.210). Analgesia requirement was significantly high in group S compared to group T immediate post op, 15, 60 minutes, 8 and 12 hours (p < 0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 and 8 hours was significantly low in group T compared to group S (p < 0.050). 30% patients in group T did not require analgesia at all compared to S (p < 0.001). Incidence of adverse effects at 4 hours was 43% in group S compared to 40% in group T (p > 0.050). Conclusion Intraperitoneal instillation of tramadol in LC has beneficial effect in terms of postoperative pain relief following LC and lower requirement of analgesia. However, the incidence of adverse effects was comparable in both the groups.