Effectiveness for pain after laparoscopic cholecystectomy of 0.5% bupivacaine-soaked Tabotamp placed in the gallbladder bed: a prospective, randomized, clinical trial.

摘要

BACKGROUND: Some scientific studies, with controversial results, have evaluated the efficacy in reducing pain of some different local anesthetic molecules, which were administered at different dosages and in different ways. The primary goal of this randomized, controlled, prospective study (Clinical Trials.gov ID NCT00599144) was to assess the effectiveness of 0.5% bupivacaine for pain control after video-laparoscopic cholecystectomy at its optimal dosage of 2 mg/kg infiltrated in the muscular fasciae of the trocars, or positioned in the gallbladder soaking a sheet of regenerated oxidized cellulose (Tabotamp). METHODS: A total of 45 patients underwent elective video-laparoscopic cholecystectomy. They were randomized in three groups each made of 15 patients: group A (bupivacaine-soaked Tabotamp positioned in the gallbladder bed), group B (bupivacaine infiltrated in the muscular fasciae of the trocars' seat), group C (control group, not using local anesthetic). Six and twenty-four hours after the intervention, the nature of the pain and its intensity were recorded with the use of a Visual Analogue Scale (VAS). RESULTS: Six hours after the intervention, VAS average was 29.6 +/- 10.92 for group A, 25.86 +/- 16.06 for group B, and 36.13 +/- 16.62 for group C. At 24 h, we recorded 19.26 +/- 15.81, 18.53 +/- 12.3, and 20.46 +/- 20.08 for groups A, B, and C, respectively (p > 0.05). Comparing groups A and B between them and with the control group at 6 and 24 h, we deduced how only the first group showed a statistically significant advantage (p < 0.05) in reducing visceral and shoulder pain compared with the two other groups. Wound infiltration resulted in being statistically favorable in reducing parietal pain only when compared with Group A. For groups A and B, bupivacaine significantly reduced the use of postoperative pain killers. CONCLUSION: Bupivacaine, either infiltrated in trocars' wounds or kept soaked in a regenerated oxidized cellulose sheet positioned in the gallbladder bed, although safe and not economically demanding, can increase postoperative comfort.