The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Metronidazole Metronidazole |
Drug: Metronidazole Oral
250 mg oral three times a day for 14 days
|
| Placebo Comparator: Placebo Halal and Kosher certified gelatin placebo capsules |
Drug: Placebo
Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days
|
Outcome Measures
Primary Outcome Measures
- 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
- Quality of life scores [1 year postoperatively.]
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
- Quality of life scores [6 months postoperatively.]
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
- Quality of life scores [6 weeks postoperatively.]
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
- Quality of life scores [5 years postoperatively.]
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
- Sexual health [6 weeks postoperatively.]
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
- Sexual health [6 months postoperatively.]
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
- Sexual health [1 year postoperatively.]
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
- 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 [1 year postoperatively.]
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
- 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.
Other Outcome Measures
- Fertility [6 months postoperatively]
Number of pregnancies and miscarriages postoperatively will be compared
- Fertility [1 year postoperatively]
Number of pregnancies and miscarriages postoperatively will be compared
- Fertility [5 years postoperatively]
Number of pregnancies and miscarriages postoperatively will be compared
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville Hospital | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
Investigators
- Principal Investigator: Resad Pasic, MD, PhD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
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