Non-Narcotic Pain Control After ACL Reconstruction

NCT06973785 | Recruiting Phase 3 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

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

Ketorolac DRUG

Patients will be randomized to either Ketorolac or Oxycodone

Also known as: Toradol

Oxycodone- Narcotic

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 and 2 week follow-up pill counts

You may not qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for t 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 and 2 week follow-up pill counts

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Cleveland Clinic Coral Springs

Coral Springs, Florida, 33067, United States

ACTIVE NOT RECRUITING

Cleveland clinic sports medicine

Garfield, Ohio, 44125, United States

RECRUITING

Cleveland Clinic

Strongsville, Ohio, 44136, United States

RECRUITING

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

Central Study Contacts

Jennifer Baldwin

CONTACT

216.390.5833; baldwij3@ccf.org

Nick Niehart

CONTACT

nieharn@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-05

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)