Combined rupivacaine peri-incisional injection and intraperitoneal nebulization: a new effective tool in pain control after laparoscopic surgery in gynecology: a randomized controlled clinical trial

Aims To evaluate the efficacy of intraoperative topical ropivacaine in the control of post-operative pain in the first 48 h after operative laparoscopy for benign adnexal or uterine pathologies. Method We conducted a prospective, randomized, double-blind, placebo-controlled clinical trial. Patients received a standard dose of topical ropivacaine (injected at the three portal sites and atomized in the abdominal cavity)or placebo. We measured the intensity of pain in the first 48 hours using VAS(visual-analogue-scale). Moreover we evaluated shoulder tip pain, the request for rescue analgesics, time to discharge from recovery room, time to mobilizing on the ward and time to return to daily activities. Patients were dividedin two groups (Group_A: benign adnexal pathologies;Group_B: benign uterine diseases) and assigned to Subgroup_1 (ropivacaine) and Subgroup_2 (placebo). Results A total of 187 women were included: 93 in Group_A and 94 in Group_B. Forty-seven patients entered Subgroup_A1, 46 Subgroup_A2, 48 Subgroup_B1 and 46Subgroup_B2. Subgroup_A1 experienced lower post-operative pain at 4(p=0.008) and 6 h(p=0.001) as well as a faster return to daily activities(p=0.01) in comparison with Subgroup_A2. Both Subgroup_A1 and Subgroup_B1 showed lower shoulder tip pain (respectively,p=0.032 and p=0.001) as well as shorter time to mobilizing on the ward after surgery (respectively,p=0.001 and p=0.01).The remaining variables analysis did not show significant results. Conclusion Combined topical analgesia with ropivacaine could represent a new safe and effective tool in the control of post-operative pain in gynecological laparoscopic surgery. Given the greater benefits for adnexal surgery, this strategy may be more suitable for this class of patients.