NCT04639011

Duloxetine Tibial Plateau

Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tibial Plateau Fracture
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Duloxetine	Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)
OTHER	Placebo	Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
OTHER	Standard of care (SOC) for tibial plateau surgery	Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-11-20
• Last updated: 2022-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study