Opioid-Free Orthopaedic Surgery (CORE)

Carolina's Opioid Reduction Effort

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: Opioids; Drug: Opioid-Free

• Study Type: Interventional
• Enrollment (Actual): 511
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Opioids; narcotic pain medicine; Other Names: Control
Active Comparator: 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.	Drug: Opioid-Free; non narcotoc pain medication; Other Names: Intervention; Non-Opioid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Nady M Hamid, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

General Publications

• Shing EZ, Leas D, Michalek C, Wally MK, Hamid N. Study protocol: randomized controlled trial of opioid-free vs. traditional perioperative analgesia in elective orthopedic surgery. BMC Musculoskelet Disord. 2021 Jan 23;22(1):104. doi: 10.1186/s12891-021-03972-9.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): July 21, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 9120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No