drugset / Trial / NCT04639011

Duloxetine Tibial Plateau

NCT04639011

Phase 4 Withdrawn Boston Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2). This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.

Timeline

Start
2022-10
Primary completion
2023-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg Oral

Indications

No indication recorded.