Clinical trial NCT04554693: The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery
Official title: The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: a Prospective, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Endometriosis
Endometriosis-related Pain
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported pain persistence
timeFrame: 6 weeks postoperatively.
Secondary outcomes:
measure: Quality of life scores
timeFrame: 1 year postoperatively.
measure: Quality of life scores
timeFrame: 6 months postoperatively.
measure: Quality of life scores
timeFrame: 6 weeks postoperatively.
measure: Quality of life scores
timeFrame: 5 years postoperatively.
measure: Sexual health
timeFrame: 6 weeks postoperatively.
measure: Sexual health
timeFrame: 6 months postoperatively.
measure: Sexual health
timeFrame: 1 year postoperatively.
measure: Sexual health
timeFrame: 5 year postoperatively.
measure: Self-reported pain persistence
timeFrame: 1 year postoperatively.
measure: Self-reported pain persistence
timeFrame: 6 months postoperatively.
Other outcomes:
measure: Fertility
timeFrame: 6 months postoperatively
measure: Fertility
timeFrame: 1 year postoperatively
measure: Fertility
timeFrame: 5 years postoperatively
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Resad Pasic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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