Recruiting
Phase 3

Gabapentin

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT02999724

Conditions

Pelvic Organ Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gabapentin

placebo

Study Details

Brief summary:

Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids.

Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.

Conditions

Pelvic Organ Prolapse

Study ID

NCT02999724

Start date

Jan, 2017

Status verified date

Feb, 2017

Completion date

Jan, 2018

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • women age 18 years and older
  • uterovaginal prolapse with or without stress urinary incontinence
  • booked for vaginal hysterectomy, anterior and/or posterior vaginal repair, with or without TVT

Exclusion Criteria:

  • Women already on gabapentin for other indications
  • Women with proven allergy or sensitivity to gabapentin
  • Women with a contraindication to gabapentin
  • Women unable to understand spoken English

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: gabapentin

gabapentin 300-600 mg 1 hour preop

placebo comparator: placebo

placebo capsule(s) 1 hour preop

Interventions

Gabapentin

Gabapentin 300-600 mg 1 hour preop

placebo

placebo capsule(s) 1 hour preop

Primary outcome measure

  • opioid consumption postop [ Time Frame: 24 hours ]

Central Contacts and Locations

Locations

Department of Obstetrics and Gynecology, Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1Z5

Contacts

Principal Investigator:

Danny Lovatsis, MD MSc

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 14, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2017-02-14.