Non-Narcotic Pain Control After ACL Reconstruction

NCT ID: NCT06973785

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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This is a multi-center, 2 arm, randomized 1:1 controlled trial, with a blinded patient and outcome assessment study. Narcotics are currently the standard of care as part multimodal pain control in major joint surgery including ACLR. Twelve (12) ketorolac (10mg) and twelve (12) oxycodone (5mg) tablets will be shrouded in identical capsules designed for blinding. The capsules will be dispensed in sealed single-pill release blister packets. The enrolled patients will be randomized by the surgeon. The surgeon, clinical team, and patient will be blinded as to treatment (double-blind study). The rescue medication will be specific to each treatment group, encapsulated for blinding, and in a packet labeled RESCUE medication. For the experimental group (ketorolac) they will have 12 oxycodone as rescue medication. For the control group (oxycodone) they will have 12 diclofenac as rescue medication. Both groups will also be given acetaminophen for the first 72 hours. All medications in our multimodal approach will be provided postoperatively after ACL reconstruction to both groups. The primary endpoint will be the percentage reduction in narcotics pills per patient in each group in first 72 hours postoperatively verified from sealed packages.

Conditions

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ACL - Anterior Cruciate Ligament Rupture ACL Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxycodone- Narcotic

Arm 1

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

Patients will be randomized to either Ketorolac or Oxycodone

Ketorolac

Arm 2

Group Type PLACEBO_COMPARATOR

dispense of study drug

Intervention Type DRUG

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

Interventions

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dispense of study drug

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

Intervention Type DRUG

Ketorolac

Patients will be randomized to either Ketorolac or Oxycodone

Intervention Type DRUG

Other Intervention Names

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oxycontin Toradol

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kurt Spindler, MD

Lead Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kurt P Spindler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Coral Springs

Coral Springs, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland clinic sports medicine

Garfield, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Strongsville, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Baldwin

Role: CONTACT

216.390.5833 ext. RC

Nick Niehart

Role: CONTACT

Facility Contacts

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Jennifer Baldwin

Role: primary

216.390.5833

Erin Clancy

Role: backup

Jennifer Baldwin

Role: primary

216.390.5833 ext. RC

Erin Clancy

Role: backup

216.970.6796

Other Identifiers

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24-1207

Identifier Type: -

Identifier Source: org_study_id

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