Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")
Status:
Unknown status
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
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.