Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2023-07-05

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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Preoperative Gabapentin/Postoperative Placebo

Group Type PLACEBO_COMPARATOR

Preoperative Gabapentin/Postoperative Placebo

Intervention Type DRUG

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.

Preoperative Gabapentin/Postoperative Gabapentin

Group Type ACTIVE_COMPARATOR

Preoperative Gabapentin/Postoperative Gabapentin

Intervention Type DRUG

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.

Interventions

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Preoperative Gabapentin/Postoperative Placebo

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.

Intervention Type DRUG

Preoperative Gabapentin/Postoperative Gabapentin

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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No