OBJECTIVE: To assess whether a superior hypogastric plexus block performed during laparoscopic hysterectomy reduces postoperative pain. METHODS: We conducted a multicenter, randomized, single-blind, controlled trial of superior hypogastric plexus block at the start of laparoscopic hysterectomy. Women undergoing a laparoscopic hysterectomy for any indication and with any other concomitant laparoscopic procedure were eligible. Standardized preoperative medications and incisional analgesia were provided to all patients. Our primary outcome was the proportion of patients with a mean visual analog scale (VAS) pain score lower than 4 within 2 hours postoperatively. Patients but not surgeons were blinded to the treatment group. Twenty-nine patients per group was estimated to be sufficient to detect a 38% absolute difference in the proportion of patients with a VAS score lower than 4 at 2 hours postoperatively, with 80% power and an α of 0.05. To account for loss to follow-up and potential imbalances in patient characteristics, we planned to enroll 50 patients per group. All analyses were intention to treat. RESULTS:Between January 2018 and February 2019, 186 patients were eligible; 100 were randomized and analyzed. Demographic and clinical characteristics were similar between the two groups. There was no significant difference in the proportion of patients with a mean VAS score lower than 4 within 2 hours postoperatively between patients who received a superior hypogastric plexus block (57%) and patients who did not (43%) (odds ratio 1.63, 95% CI 0.74-3.59; adjusted odds ratio 1.84, 95% CI 0.75-4.51). CONCLUSION: Among patients undergoinglaparoscopic hysterectomy with standardized enhanced perioperative recovery pathways, superior hypogastric plexus block did not significantly reduce postoperative pain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03283436.
RCT Entities:
OBJECTIVE: To assess whether a superior hypogastric plexus block performed during laparoscopic hysterectomy reduces postoperative pain. METHODS: We conducted a multicenter, randomized, single-blind, controlled trial of superior hypogastric plexus block at the start of laparoscopic hysterectomy. Women undergoing a laparoscopic hysterectomy for any indication and with any other concomitant laparoscopic procedure were eligible. Standardized preoperative medications and incisional analgesia were provided to all patients. Our primary outcome was the proportion of patients with a mean visual analog scale (VAS) pain score lower than 4 within 2 hours postoperatively. Patients but not surgeons were blinded to the treatment group. Twenty-nine patients per group was estimated to be sufficient to detect a 38% absolute difference in the proportion of patients with a VAS score lower than 4 at 2 hours postoperatively, with 80% power and an α of 0.05. To account for loss to follow-up and potential imbalances in patient characteristics, we planned to enroll 50 patients per group. All analyses were intention to treat. RESULTS: Between January 2018 and February 2019, 186 patients were eligible; 100 were randomized and analyzed. Demographic and clinical characteristics were similar between the two groups. There was no significant difference in the proportion of patients with a mean VAS score lower than 4 within 2 hours postoperatively between patients who received a superior hypogastric plexus block (57%) and patients who did not (43%) (odds ratio 1.63, 95% CI 0.74-3.59; adjusted odds ratio 1.84, 95% CI 0.75-4.51). CONCLUSION: Among patients undergoing laparoscopic hysterectomy with standardized enhanced perioperative recovery pathways, superior hypogastric plexus block did not significantly reduce postoperative pain. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03283436.