Carolina's Opioid Reduction Effort
Overview
- Phase
- Not Applicable
- Intervention
- Opioids
- Conditions
- Pain Management
- Sponsor
- OrthoCarolina Research Institute, Inc.
- Enrollment
- 511
- Locations
- 1
- Primary Endpoint
- Pain at 24 hours postop
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Opioid
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.
Intervention: Opioids
Opioid-Free
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.
Intervention: Opioid-Free
Outcomes
Primary Outcomes
Pain at 24 hours postop
Time Frame: 24 hours
Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score
Secondary Outcomes
- Pain at 1 year postop(1 year)
- General Health(1 year)
- Pain at 12 hours postop(12 hours)
- Pain at 2 weeks postop(2 weeks)
- Pain at 6 weeks postop(6 weeks)
- Pain at 6 hours postop(6 hours)