Opioid-Free Orthopaedic Surgery

Pain Management Clinical Trial

— CORE  

Official title:

Carolina's Opioid Reduction Effort

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176783
• Other study ID #: 9120
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 26, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 511
• Est. completion date: December 31, 2024
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain Management

Intervention

Drug:
• Opioids
narcotic pain medicine
• Opioid-Free
non narcotoc pain medication

Locations

Country	Name	City	State
United States	OrthoCarolina, P.A.	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at 24 hours postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	24 hours
Secondary	Pain at 6 hours postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	6 hours
Secondary	Pain at 12 hours postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	12 hours
Secondary	Pain at 2 weeks postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	2 weeks
Secondary	Pain at 6 weeks postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	6 weeks
Secondary	Pain at 1 year postop	Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score	1 year
Secondary	General Health	Veterans Rand-12	1 year