Adrienne L K Li1, Kristin Wadsworth2, Naveed T Siddiqui3, May Alarab2, Colleen D McDermott2, Nucelio Lemos2, Ashraf Dawood4, Danny Lovatsis2. 1. Department of Obstetrics and Gynecology, Mount Sinai Hospital, Room 8 - 814, 700 University Avenue, Toronto, ON, M5G 1Z5, Canada. adrienne.li@sinaihealthsystem.ca. 2. Department of Obstetrics and Gynecology, Mount Sinai Hospital, Room 8 - 814, 700 University Avenue, Toronto, ON, M5G 1Z5, Canada. 3. Department of Anesthesia and Pain Management, Mount Sinai Hospital, Toronto, ON, Canada. 4. Department of Obstetrics and Gynecology, Women's Specialized Hospital, King Fahad Medical City, Saudi Arabia.
Abstract
INTRODUCTION AND HYPOTHESIS: Pre-emptive gabapentin has been shown to decrease postoperative pain in abdominal and vaginal hysterectomy. However, the effect of pre-emptive low-dose gabapentin has not been studied in vaginal hysterectomy combined with concomitant pelvic reconstruction. METHODS: A randomized double-blind placebo-controlled trial assessed all women seen for symptomatic prolapse requiring vaginal hysterectomy with concomitant pelvic reconstruction with or without midurethral sling. Gabapentin dosing was 600 mg (<65 years) or 300 mg (>65 years). The primary outcome was reduction in opioid consumption in the first 24 h after surgery. Secondary outcomes included sedation and prolongation of recovery room stay. Sample-size calculations indicated a need for 22 participants/group. Student's t test was used to compare differences in oral administration of morphine equivalents in the first 24 h postoperatively, time from end of surgery to leaving the recovery room, and length of recovery room stay. Mann-Whitney U test was used to compare visual analog scale (VAS) scores for anxiety, drowsiness/sedation, pain, and nausea. RESULTS: Twenty-one patients received gabapentin and 26 a placebo capsule. Groups were similar with respect to age, menopause status, parity, American Society of Anesthesiologist (ASA) class, and concomitant procedures. There were also no significant differences between groups in opioid requirements within the first 24 h after surgery, time from end of surgery to leaving the recovery room, length of time in recovery room, or VAS scores. CONCLUSIONS:Pre-emptive gabapentin at our institutional low doses did not significantly affect postoperative pain and opioid requirements in women undergoing vaginal hysterectomy with concomitant reconstruction. TRIAL REGISTRATION: www.clinicaltrials.gov , #NCT02999724.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: Pre-emptive gabapentin has been shown to decrease postoperative pain in abdominal and vaginal hysterectomy. However, the effect of pre-emptive low-dose gabapentin has not been studied in vaginal hysterectomy combined with concomitant pelvic reconstruction. METHODS: A randomized double-blind placebo-controlled trial assessed all women seen for symptomatic prolapse requiring vaginal hysterectomy with concomitant pelvic reconstruction with or without midurethral sling. Gabapentin dosing was 600 mg (<65 years) or 300 mg (>65 years). The primary outcome was reduction in opioid consumption in the first 24 h after surgery. Secondary outcomes included sedation and prolongation of recovery room stay. Sample-size calculations indicated a need for 22 participants/group. Student's t test was used to compare differences in oral administration of morphine equivalents in the first 24 h postoperatively, time from end of surgery to leaving the recovery room, and length of recovery room stay. Mann-Whitney U test was used to compare visual analog scale (VAS) scores for anxiety, drowsiness/sedation, pain, and nausea. RESULTS: Twenty-one patients received gabapentin and 26 a placebo capsule. Groups were similar with respect to age, menopause status, parity, American Society of Anesthesiologist (ASA) class, and concomitant procedures. There were also no significant differences between groups in opioid requirements within the first 24 h after surgery, time from end of surgery to leaving the recovery room, length of time in recovery room, or VAS scores. CONCLUSIONS: Pre-emptive gabapentin at our institutional low doses did not significantly affect postoperative pain and opioid requirements in women undergoing vaginal hysterectomy with concomitant reconstruction. TRIAL REGISTRATION: www.clinicaltrials.gov , #NCT02999724.
Authors: Michael G F Rorarius; Susanna Mennander; Pentti Suominen; Sirpa Rintala; Arto Puura; Raili Pirhonen; Raili Salmelin; Maija Haanpää; Erkki Kujansuu; Arvi Yli-Hankala Journal: Pain Date: 2004-07 Impact factor: 6.961