NCT04768478

CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF

The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Ankle and Tibia Fracture Open Reduction and Internal Fixation. A Double-Blind, Randomized Control Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of administering CBD to control post-operative pain in patients undergoing ankle fracture open reduction and internal fixation, tibial plafond (pilon) open reduction and internal fixation, tibial shaft repair (open reduction internal fixation or intramedullary nail fixation), or tibial plateau open reduction and internal fixation. Secondly, the purpose is to evaluate the effectiveness of CBD in comparison with opioid therapy for post-operative pain.

Conditions

• Ankle Fractures
• Tibia Fracture

Interventions

Type	Name	Description
DRUG	CBD	25mg CBD ODTs (orally disintegrating tablet), with instructions to take CBD tablets t.i.d. (total of 50mg per dose t.i.d.) to be administered with routine post-operative pain management
DRUG	Placebo	Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-31
• First posted: 2021-02-24
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study