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Opioid-Free Orthopaedic Surgery

NCT04176783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2025-03-20

No results posted yet for this study

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

DRUG

Opioids

narcotic pain medicine

DRUG

Opioid-Free

non narcotoc pain medication

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Nady M Hamid, MD · OrthoCarolina Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176783 on ClinicalTrials.gov