NCT04176783

Opioid-Free Orthopaedic Surgery

Carolina's Opioid Reduction Effort

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol. Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.

Conditions

• Pain Management

Interventions

Type	Name	Description
DRUG	Opioids	narcotic pain medicine
DRUG	Opioid-Free	non narcotoc pain medication

Timeline

• Start date: 2018-03-26
• Primary completion: 2021-07-21
• Completion: 2024-12-31
• First posted: 2019-11-25
• Last updated: 2025-03-20

Locations

1 site across 1 country: United States