Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

NCT02999724 | Unknown Phase 3

• 1 other identifier: 16-0262-A
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• opioid consumption postop

  total opioid use 24 hours after surgery

  24 hours

Study Arms (2)

gabapentin

EXPERIMENTAL

gabapentin 300-600 mg 1 hour preop

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

placebo capsule(s) 1 hour preop

Other: placebo

Interventions

Gabapentin DRUG

Gabapentin 300-600 mg 1 hour preop

gabapentin

placebo OTHER

placebo capsule(s) 1 hour preop

Also known as: placebo capsule

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

RECRUITING

Related Publications (1)

• Li ALK, Wadsworth K, Siddiqui NT, Alarab M, McDermott CD, Lemos N, Dawood A, Lovatsis D. Does low-dose gapapentin reduce opioid use postoperatively?: A randomized controlled trial in women undergoing reconstructive pelvic surgery. Int Urogynecol J. 2019 Feb;30(2):211-217. doi: 10.1007/s00192-018-3617-3. Epub 2018 Mar 21.

  PMID: 29564507 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Danny Lovatsis, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny Lovatsis, MD

CONTACT

416-586-4566; danny.lovatsis@sinaihealthsystem.ca

Adrienne Li, MD

CONTACT

416-586-4566; adrienne.lk.li@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 14, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)