Opioid-Free Pain Control for Orthopaedic Surgery Recovery

(CORE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Anticoagulants, NSAIDs

Disqualifiers: Chronic opioid therapy, Liver disease, Alcohol dependence, Sickle cell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: Immediate postoperative period

511 Participants Needed

Trial Summary

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.

Research Team

Nady M Hamid, MD

Principal Investigator

OrthoCarolina Research Institute, Inc.

Eligibility Criteria

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

You had surgery on one or two levels of your neck for degenerative disease.

You have had a knee procedure called arthroscopy to diagnose and possibly remove damaged tissue in the knee joint.

Patient is scheduled to undergo one of the following procedures:

Exclusion Criteria

Outpatient THA or TSA/RTSA

Workers compensation

You have a problem with drinking too much alcohol and are dependent on it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with either an opioid-based or opioid-free pain control protocol

Immediate postoperative period

Inpatient surgical visit

Follow-up

Participants are monitored for pain and recovery outcomes at various time points post-surgery

1 year

Multiple visits at 6 hours, 12 hours, 24 hours, 2 weeks, 6 weeks, and 1 year post-surgery

Treatment Details

Interventions

• Opioid-Free

Trial Overview The study compares two pain management methods after routine orthopaedic surgery: one uses opioids and the other an opioid-free approach. Patient comfort, satisfaction with surgery and recovery, pain control effectiveness and side effects like constipation and falls will be measured.

Participant Groups

Group I: Opioid Active Control 1 Intervention

The opioid-based arm utilizes traditional, standard-of-care treatment for each applicable surgery. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications in the opioid family such as Hydromorphone, Hydrocodone, Tramadol, or Oxycodone.

Group II: Opioid-Free Active Control 1 Intervention

The opioid-free arm utilizes medications that do not belong to the opioid family of medications. All medications used are FDA-approved and no experimental medications are being used. The medications (including dosage and frequency) used in this arm vary depending on the surgery being performed; however, tend to include medications such as Gabapentin, Tylenol, Meloxicam, Bupivacaine, or Ketorolac.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+