Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Indiana University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Preoperative Gabapentin/Postoperative Placebo; Drug: Preoperative Gabapentin/Postoperative Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05494385

OBGYN-IIR-PERI-OP-GABAPENTIN

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 2 patient groups, including a placebo group

Preoperative Gabapentin/Postoperative Placebo

Placebo Comparator group

Treatment:

Drug: Preoperative Gabapentin/Postoperative Placebo

Preoperative Gabapentin/Postoperative Gabapentin

Active Comparator group

Treatment:

Drug: Preoperative Gabapentin/Postoperative Gabapentin