Opioid-Free Pain Control for Orthopaedic Surgery Recovery
(CORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Nady M Hamid, MD
Principal Investigator
OrthoCarolina Research Institute, Inc.
Are You a Good Fit for This Trial?
This trial is for adults needing certain orthopaedic surgeries, like spine or joint replacements, without a history of substance dependence, significant liver disease, renal insufficiency, GI bleeding/ulcers, or chronic opioid use. It excludes those on workers' comp., with alcohol dependence, taking strong anticoagulants (except aspirin), having outpatient procedures or revision surgeries.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery with either an opioid-based or opioid-free pain control protocol
Follow-up
Participants are monitored for pain and recovery outcomes at various time points post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Opioid-Free
Find a Clinic Near You
Who Is Running the Clinical Trial?
OrthoCarolina Research Institute, Inc.
Lead Sponsor