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Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")

NCT02999724 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-02-14

No results posted yet for this study

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

Interventions

DRUG

Gabapentin

Gabapentin 300-600 mg 1 hour preop

OTHER

placebo

placebo capsule(s) 1 hour preop

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Danny Lovatsis, MD · Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-09-30
Completion
2018-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02999724 on ClinicalTrials.gov