drugset / Trial / NCT04176783

Opioid-Free Orthopaedic Surgery

NCT04176783 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-03-26
Primary completion
2021-07-21
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule — —
Subject Bupivacaine Other / unclassified — —
Subject Gabapentin Unknown — —
Subject Hydrocodone Unknown — —
Subject Hydromorphone Other / unclassified — —
Subject Ketorolac Other / unclassified — —
Subject Meloxicam Small molecule — —
Subject Oxycodone Other / unclassified — —
Subject Tramadol Other / unclassified — —

Indications

No indication recorded.