Are Opioids Needed After ACL Reconstruction

NCT04285853 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00116728
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief Summary

As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

Opioids

Outcome Measures

Primary Outcomes (1)

• Pain Level: Numeric Rating Scale

  Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).

  Postoperative days 0-6

Other Outcomes (3)

• Change in Pain Threshold Testing

  Postoperative days 0-6, 6 weeks post-surgery

• Change in Pain Catastrophizing Scale (PCS)

  Postoperative days 0-6, 6 weeks post-surgery

• Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D

  Postoperative days 0-6, 6 weeks post-surgery

Study Arms (2)

Oxycodone Arm

EXPERIMENTAL

Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management.

Drug: Oxycodone

Placebo Arm

PLACEBO COMPARATOR

Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care: 1. Oral non-opioid (1000 mg acetaminophen), every 8 hours. 2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. 3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. 4. Intraoperative education on post-surgical pain management.

Drug: Placebo oral tablet

Interventions

Oxycodone DRUG

5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10

Also known as: Xtampza ER, Oxaydo, Roxicodone, and Oxycontin

Oxycodone Arm

Placebo oral tablet DRUG

Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Placebo Arm

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females
• Aged 14-40 years
• Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.

You may not qualify if:

• Revision and/or contralateral ACL reconstruction procedures
• Allergies to local anesthetics
• Chronic pain medication use
• Weight \<50 kg, local infections
• Known coagulopathies,
• Liver dysfunction or renal failure

Sponsors & Collaborators

• Emory University: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (3)

The Emory Clinic

Atlanta, Georgia, 30324, United States

Location

Emory clinic at Executive Park

Atlanta, Georgia, 30329, United States

Location

Emory Orthopedic and spine Hospital

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. John Xerogeanes
• Organization: Emory University

jxeroge@emory.edu

404-778-7202

Study Officials

• John Xerogeanes, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, double-blind, randomized controlled clinical trial

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: September 16, 2020
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)