Opioid-Free Orthopaedic Surgery

NCT04176783 | Completed DMC

• 1 other identifier: 9120
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain at 24 hours postop

  Numeric Pain Rating Scale 0-10, with 10 representing the highest/worst pain score

  24 hours

Secondary Outcomes (6)

• Pain at 6 hours postop

  6 hours

• Pain at 12 hours postop

  12 hours

• Pain at 2 weeks postop

  2 weeks

• Pain at 6 weeks postop

  6 weeks

• Pain at 1 year postop

  1 year

Study Arms (2)

Opioid

ACTIVE COMPARATOR

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

Opioid-Free

ACTIVE COMPARATOR

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

Interventions

Opioids DRUG

narcotic pain medicine

Also known as: Control

Opioid

Opioid-Free DRUG

non narcotoc pain medication

Also known as: Intervention, Non-Opioid

Opioid-Free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• Revision surgery for one of the study-specific procedures
• Chronic opioid therapy - per investigator discretion
• Fracture or soft tissue injury
• Sickle cell disease
• Workers compensation
• Alcohol dependence
• Contra-indication to regional anesthesia
• History of gastrointestinal (GI) bleeding or peptic ulcer
• History of bleeding problems
• Patients taking anticoagulants, not including aspirin (only applies to Randomized portion of study. These patients can still participate in Observational Control Group)
• Renal insufficiency - Creatinine clearance less than 30 mL/min (only applies to patients having surgery requiring NSAIDs treatment)
• Outpatient THA or TSA/RTSA
• Allergy to non-steroidal anti-inflammatory medications (NSAIDs)

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina, P.A.

Charlotte, North Carolina, 28207, United States

Location

Related Publications (1)

• 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.

  PMID: 33485328 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Opioid; Methods; Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Investigative Techniques

Study Officials

• Nady M Hamid, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: November 25, 2019
• Study Start: March 26, 2018
• Primary Completion: July 21, 2021
• Study Completion: December 31, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)