Opioid-Free Orthopaedic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Carolina's Opioid Reduction Effort

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Opioids
* Drug: Opioid-Free


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 1. Patient is scheduled to undergo one of the following procedures: Primary single-level or two-level ACDF or ACDA for degenerative disease Primary 1st CMC arthroplasty Primary Hallux Valgus or Hallux Rigidus correction Diagnostic knee arthroscopy +/- meniscal debridement Elective primary total shoulder or reverse total shoulder arthroplasty Primary total hip arthroplasty Exclusion Criteria Revision surgery for one of the study-specific procedures Chronic opioid therapy - per investigator discretion Significant liver disease - (NOTE: Patients with a history of liver disease will have a hepatic panel drawn to be reviewed by the study investigator to asses if the values are within acceptable limits for inclusion in the study) Fracture or soft tissue injury Sickle cell disease Workers compensation Alcohol dependence Contra-indication to regional anesthesia History of gastrointestinal (GI) bleeding or peptic ulcer History of bleeding problems Patients taking anticoagulants, not including aspirin (only applies to Randomized portion of study. These patients can still participate in Observational Control Group) Renal insufficiency - Creatinine clearance less than 30 mL/min (only applies to patients having surgery requiring NSAIDs treatment) Outpatient THA or TSA/RTSA Hammertoe in isolation (Hallux Valgus/Rigidus exclusion only) Concomitant meniscal repair or microfracture (Knee Arthroscopy exclusion only) Ineligible for spinal anesthesia (THA exclusion only) Previous ipsilateral hip surgery, not including hip scope (THA exclusion only) Allergy to non-steroidal anti-inflammatory medications (NSAIDs)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid<br>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. | Drug: Opioids<br>* narcotic pain medicine<br>* Other names: Control;|
| Active Comparator: Opioid-Free<br>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. | Drug: Opioid-Free<br>* non narcotoc pain medication<br>* Other names: Non-Opioid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at 24 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at 6 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 6 hours | 
| Pain at 12 hours postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 12 hours | 
| Pain at 2 weeks postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 2 weeks | 
| Pain at 6 weeks postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 6 weeks | 
| Pain at 1 year postop | Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score | 1 year | 
| General Health | Veterans Rand-12 | 1 year |