Non-Narcotic Pain Control After ACL Reconstruction

NCT06973785 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-1207
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.

Conditions

ACL - Anterior Cruciate Ligament Rupture; ACL Injuries

Keywords

acl; Narcotic use

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  How many narcotic pills were consumed

  30 days

Study Arms (2)

Oxycodone- Narcotic

ACTIVE COMPARATOR

Arm 1

Drug: Ketorolac

Ketorolac

PLACEBO COMPARATOR

Arm 2

Drug: dispense of study drug

Interventions

Ketorolac DRUG

Patients will be randomized to either Ketorolac or Oxycodone

Also known as: Toradol

Oxycodone- Narcotic

dispense of study drug DRUG

• Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen

Also known as: oxycontin

Ketorolac

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 15-55 years
• Primary Autograft ACL surgery
• Ability to take oral medication and willingness to patriciate in a virtual 1 week follow-up pill count visit

You may not qualify if:

• \. Any extensor mechanism dislocation or disruption 2. Multi-ligament injury that requires repair 3. Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control 4. Psychiatric illness that impedes evaluation of pain and/or narcotics use 5. History of Chronic Kidney Disease 6. History of inflammatory arthritis, diabetes, or autoimmune disease 7. History of GI bleed or documented GI ulcer (diagnosed by endoscopy) 8. Allograft or revision of ACLR 9. Contraindications to ketorolac or opioids

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Cleveland Clinic Coral Springs

Coral Springs, Florida, 33067, United States

Location

Cleveland clinic sports medicine

Garfield, Ohio, 44125, United States

Location

Cleveland Clinic

Strongsville, Ohio, 44136, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Oxycodone; Ketorolac; Ketorolac Tromethamine

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; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Kurt P Spindler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 15, 2025
• Study Start: July 15, 2025
• Primary Completion: June 12, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: They will be available from the start date to the end date

Locations

US (3)