Clinical trial NCT04176783: Opioid-Free Orthopaedic Surgery
Official title: Carolina's Opioid Reduction Effort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Pain at 24 hours postop
timeFrame: 24 hours
Secondary outcomes:
measure: Pain at 6 hours postop
timeFrame: 6 hours
measure: Pain at 12 hours postop
timeFrame: 12 hours
measure: Pain at 2 weeks postop
timeFrame: 2 weeks
measure: Pain at 6 weeks postop
timeFrame: 6 weeks
measure: Pain at 1 year postop
timeFrame: 1 year
measure: General Health
timeFrame: 1 year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, P.A.
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Nady M Hamid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.