Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Preoperative Gabapentin/Postoperative Placebo
* Drug: Preoperative Gabapentin/Postoperative Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women > 18 years old English-speaking Stage > 2 pelvic organ prolapse Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure) Planning overnight stay Exclusion Criteria: Renal dysfunction (creatinine clearance <60 mL/min) Allergy to acetaminophen and ibuprofen Allergy to gabapentin Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Preoperative Gabapentin/Postoperative Placebo<br> | Drug: Preoperative Gabapentin/Postoperative Placebo<br>* 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.<br>|
| Active Comparator: Preoperative Gabapentin/Postoperative Gabapentin<br> | Drug: Preoperative Gabapentin/Postoperative Gabapentin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Length of postoperative hospital stay (typically less than 48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. Pain score collected will be pain recorded at 12 hours after arrival to the floor and highest score during hospital stay | Length of postoperative hospital stay (typically less than 48 hours) | 
| 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. | Length of postoperative hospital stay (typically less than 48 hours) | 
| Length of Stay | Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital. | Length of postoperative hospital stay (typically less than 48 hours) | 
| Nausea | Nausea will be measured by the number of as needed antiemetics the patient received postoperatively. | Length of postoperative hospital stay (typically less than 48 hours) | 
| 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. | Length of postoperative hospital stay (typically less than 48 hours) |