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

Study Overview
=================
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.

Official Title
-----------------
The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: A Prospective, Randomized, Placebo-Controlled Trial

Conditions
-----------------
Endometriosis, Endometriosis-related Pain

Intervention / Treatment
-----------------
* Drug: Metronidazole Oral
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronidazole<br>Metronidazole | Drug: Metronidazole Oral<br>* 250 mg oral three times a day for 14 days<br>|
| Placebo Comparator: Placebo<br>Halal and Kosher certified gelatin placebo capsules | Drug: Placebo<br>* Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life scores | Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome | 1 year postoperatively. | 
| Quality of life scores | Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome | 6 months postoperatively. | 
| Quality of life scores | Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome | 6 weeks postoperatively. | 
| Quality of life scores | Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome | 5 years postoperatively. | 
| Sexual health | Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction | 6 weeks postoperatively. | 
| Sexual health | Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction | 6 months postoperatively. | 
| Sexual health | Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction | 1 year postoperatively. | 
| Sexual health | Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction | 5 year postoperatively. | 
| 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. | 1 year postoperatively. | 
| 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. | 6 months postoperatively. |