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

Phase 4

Recruiting

• Conditions: Endometriosis-related Pain; Endometriosis
• Interventions: Drug: Metronidazole Oral; Drug: Placebo

• Registration Number: NCT04554693
• Lead Sponsor: University of Louisville

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-09-05
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-18
• Study Start: 2020-10-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole	Metronidazole Oral	Metronidazole
Placebo	Placebo	Halal and Kosher certified gelatin placebo capsules

Primary Outcome Measures

Name	Time	Method
Self-reported pain persistence	6 weeks postoperatively.	The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Secondary Outcome Measures

Name	Time	Method
Quality of life scores	5 years postoperatively.	Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Sexual health	5 year postoperatively.	Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Self-reported pain persistence	6 months postoperatively.	The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States