A randomized, placebo-controlled, double-blind study of hysteroscopic-guided pertubal diluted bupivacaine infusion for endometriosis-associated chronic pelvic pain
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Abstract
OBJECTIVE: To assess the effectiveness of hysteroscopic-guided pertubal diluted bupivacaine infusion for endometriosis-associated chronic pelvic pain (CPP).
METHODS: Between June 2010 and July 2013, a randomized, placebo-controlled, double-blind study was undertaken at Mansoura University Hospital, Mansoura, Egypt. Patients meeting inclusion criteria (laparoscopically confirmed endometriosis, patent fallopian tubes, ≥6 months CPP, pain score on visual analogue scale [VAS] >5) were randomly assigned using a computer-generated randomization sequence to receive either office hysteroscopic-guided pertubal diluted bupivacaine infusion (0.25%) or placebo. Response to treatment was assessed using subjective data for scores on VAS and a monthly verbal rating scale (VRSmonthly) at baseline and at 1, 2, and 3 months of follow-up. Additionally, women completed a questionnaire to evaluate the overall satisfaction at 3 months.
RESULTS: Thirty patients were assigned to each group. In the bupivacaine group, VAS and VRSmonthly scores were significantly lower at 1, 2, and 3 months than at baseline (P<0.05 for all). Additionally, scores were significantly lower in the bupivacaine group than in the placebo group at 1, 2, and 3 months (P<0.05 for all). At 3 months, 22 (73%) women in the bupivacaine group expressed satisfaction, compared with 2 (7%) in the placebo group (P=0.18).
CONCLUSION: Office pertubal hysteroscopic-guided diluted bupivacaine infusion could be used to manage endometriosis-associated CPP for at least 3 months. AEARCTR-0000573.
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Courtesy of the U.S. National Library of Medicine
Courtesy of the U.S. National Library of Medicine