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

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ClinicalTrials.gov Identifier: NCT04554693
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : October 27, 2023
Sponsor:
Information provided by (Responsible Party):
Resad Pasic, University of Louisville

Study Description
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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
Endometriosis Endometriosis-related Pain Drug: Metronidazole Oral Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: A Prospective, Randomized, Placebo-Controlled Trial
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Self-reported pain persistence [ Time Frame: 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 :
  1. Quality of life scores [ Time Frame: 1 year postoperatively. ]
    Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome

  2. Quality of life scores [ Time Frame: 6 months postoperatively. ]
    Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome

  3. Quality of life scores [ Time Frame: 6 weeks postoperatively. ]
    Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome

  4. Quality of life scores [ Time Frame: 5 years postoperatively. ]
    Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome

  5. Sexual health [ Time Frame: 6 weeks postoperatively. ]
    Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction

  6. Sexual health [ Time Frame: 6 months postoperatively. ]
    Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction

  7. Sexual health [ Time Frame: 1 year postoperatively. ]
    Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction

  8. Sexual health [ Time Frame: 5 year postoperatively. ]
    Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction

  9. Self-reported pain persistence [ Time Frame: 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.

  10. Self-reported pain persistence [ Time Frame: 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:
  1. Fertility [ Time Frame: 6 months postoperatively ]
    Number of pregnancies and miscarriages postoperatively will be compared

  2. Fertility [ Time Frame: 1 year postoperatively ]
    Number of pregnancies and miscarriages postoperatively will be compared

  3. Fertility [ Time Frame: 5 years postoperatively ]
    Number of pregnancies and miscarriages postoperatively will be compared


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female participants
Accepts Healthy Volunteers:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554693


Contacts
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Contact: Amira Quevedo, MD 5025884400 amira.quevedo@uoflhealth.org
Contact: Resad Pasic, MD, PhD 5025884400 resad.pasic@louisville.edu

Locations
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United States, Kentucky
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: AMIRA QUEVEDO, MD    502-588-4400    amira.quevedo@uoflhealth.org   
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Resad Pasic, MD, PhD University of Louisville
More Information
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Publications:

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Responsible Party: Resad Pasic, Director, Fellowship in Advanced Gynecologic Endoscopy, Department of Obstetrics and Gynecology and Woman's Health, University of Louisville School of Medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT04554693    
Other Study ID Numbers: 200544
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: October 27, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents