Clinical trial NCT04659317: Opioid-Free Orthopaedics
Official title: A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Pain, Postoperative
Keywords: Pain management
Oxycodone
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Detailed description: Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Eligibility criteria: Inclusion Criteria:

* Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
* Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
* Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
* Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
* Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Exclusion Criteria:

* Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C \>9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications.i. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
* Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
* Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Primary outcomes:
measure: Change in Pain (VAS) Score
timeFrame: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
Secondary outcomes:
measure: Change in patient Satisfaction Scores
timeFrame: Three times a day postoperatively for the first 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
measure: Change in opioid consumption
timeFrame: Baseline, 60 months post operative
measure: Change in associated side effects
timeFrame: Postoperatively for the first 14 days, and then 6 weeks, 3 months, 6 months, 12 months, 24 months, 60 months postoperative
measure: Change in Single Assessment Numeric Evaluation (SANE) score
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 60 months postoperative
measure: Change in American Shoulder and Elbow Surgeons Index Scale (ASES)
timeFrame: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
measure: Change in European Quality of Life 5 dimension (EQ-5D)
timeFrame: baseline (preoperative), 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 60 months postoperative
measure: Length of stay postoperative
timeFrame: End of the trial (up to 60 months post operative)
measure: Number of complications
timeFrame: End of the trial (up to 60 months post operative)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Tucker
country: United States
facility: Emory Orthopedic and Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Eric Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: