Phase 4
N=114
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT05494385 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Opioid Prescription at Discharge — 40; 40; 19; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Preoperative Gabapentin/Postoperative Placebo (Drug); Preoperative Gabapentin/Postoperative Gabapentin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Prescription at Discharge |
40; 40; 19; 15 | — |
| SECONDARY Opioid Refill Requests |
50; 49; 9; 6 | — |
| SECONDARY Inpatient Pain Scores |
6; 7 | — |
| SECONDARY Inpatient Morphine Milligram Equivalents |
15; 7.5 | — |
| SECONDARY Length of Stay |
32.8; 31.0 | — |
| SECONDARY Nausea |
0; 0 | — |
| SECONDARY Sedation |
13; 15; 19; 15; 8; 12 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05494385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.