The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
Indiana University School of Medicine
Indianapolis, Indiana, United States
Opioid Prescription at Discharge
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Time frame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
Opioid Refill Requests
Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Time frame: 6 weeks
Inpatient Pain Scores
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded.
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Inpatient Morphine Milligram Equivalents
Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Length of Stay
Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Time frame: Time of registration for surgery to time of discharge from hospital
Nausea
Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
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Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
Sedation
Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.
Time frame: On postoperative day 1 between 6AM and 10AM