The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

Phase 4TerminatedNCT04554693

University of Louisville78 enrolled

Overview

The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.

The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study. Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days. Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Endometriosis Endometriosis-related Pain

Interventions

Metronidazole OralDRUG

250 mg oral three times a day for 14 days

PlaceboDRUG

Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Able to give informed consent * Women aged 18-50 years old * Scheduled to undergo excision of endometriosis * Able to read and write in English and or Spanish * Pain score \> 2 on a 10 point visual analogue scale at baseline * Negative screening by CAGE questionnaire Exclusion Criteria: * Refusal to surgery * Contraindication to surgery * Known allergy to metronidazole * Known allergy to any component in gelatin placebo capsules * Scheduled hysterectomy * Endometriosis excision surgery within the last 3 months * Elevated serum creatinine * Abnormal liver function test greater than 2 times the normal * Current pregnancy * Breastfeeding * Use of Disulfiram within the last 2 weeks * History of Cockayne syndrome * Inability to abstain from alcohol during the use of study drug

Locations (1)

University of Louisville Hospital

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Percentage of Participants With Self Reported Pain Persistence

The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Time frame: 6 weeks postoperatively.

Secondary Outcomes

Quality of Life Via Endometriosis Health Profile-5

Endometriosis Health Profile-5 on scale of 0-100, with higher scores meaning worse outcome, using continuous variables reported as means.

Time frame: 6 weeks postoperatively.

Sexual Health Via Female Sexual Function Index

Female sexual function index on a scale of 2-36 with higher scores meaning higher sexual dysfunction

Time frame: 6 weeks postoperatively.

Percentage of Participants With Self Reported Pain Persistence

The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Time frame: 6 months postoperatively.

Percentage of Participants With Self Reported Pain Persistence

The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Time frame: 1 year postoperatively.

Data from ClinicalTrials.gov

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