Opioid-Free Orthopaedic Surgery (CORE)

OrthoCarolina Research Institute, Inc.

Status: Active, not recruiting

Conditions: Pain Management

Treatments: Drug: Opioids; Drug: Opioid-Free

Study type: Interventional

Funder types: Other

Identifiers

NCT04176783

9120

Details and patient eligibility

About

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.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

1. Revision surgery for one of the study-specific procedures
2. Chronic opioid therapy - per investigator discretion
3. 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)
4. Fracture or soft tissue injury
5. Sickle cell disease
6. Workers compensation
7. Alcohol dependence
8. Contra-indication to regional anesthesia
9. History of gastrointestinal (GI) bleeding or peptic ulcer
10. History of bleeding problems
11. Patients taking anticoagulants, not including aspirin (only applies to Randomized portion of study. These patients can still participate in Observational Control Group)
12. Renal insufficiency - Creatinine clearance less than 30 mL/min (only applies to patients having surgery requiring NSAIDs treatment)
13. Outpatient THA or TSA/RTSA
14. Hammertoe in isolation (Hallux Valgus/Rigidus exclusion only)
15. Concomitant meniscal repair or microfracture (Knee Arthroscopy exclusion only)
16. Ineligible for spinal anesthesia (THA exclusion only)
17. Previous ipsilateral hip surgery, not including hip scope (THA exclusion only)
18. Allergy to non-steroidal anti-inflammatory medications (NSAIDs)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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511 participants in 2 patient groups

Opioid

Active Comparator group

Description:

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.

Treatment:

Drug: Opioids

Opioid-Free

Active Comparator group

Description:

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.

Treatment:

Drug: Opioid-Free