drugset / Trial / NCT04230980

Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery

NCT04230980 ↗

Phase 3 Completed 74 enrolled Weill Medical College of Cornell University
RandomizedParallel-groupDouble-blindTreatment

Summary

The use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative and post-operative period to reduce or potentially eliminate narcotic usage following scrotal surgery. Research study results have shown that the use of anti-inflammatories in the peri-operative period reduces both pain and narcotic use. The hypothesis is that adding another agent in the multi-modal pathway will further reduce pain and potentially reduce narcotic usage.

Timeline

Start
2020-07-28
Primary completion
2022-11-28
Completion
2022-12-16

Outcome

Met primary endpoint

registry analysis (superiority test); Gabapentin vs Placebo; p = 0.01; Mean Difference (Final Values) -1.13 (95% CI -2.02 to -0.24); t-test, 2 sided NCT04230980 ↗

paper final mean pain score differences (-1.27, 95% CI -2.23 to -0.32, P = .0097) indicated lower gabapentin pain compared to placebo. PMID 38382042 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Unknown 300 mg —

Indications