Non-Narcotic Pain Control After ACL Reconstruction

Part of paid clinical trials in Coral Springs, Florida.

Sponsor
The Cleveland Clinic
Study ID
NCT06973785
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • ACL - Anterior Cruciate Ligament Rupture
  • ACL Injuries

Eligibility Criteria

Sex
ALL
Age
15 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • dispense of study drug — DRUG
    • Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen
  • Ketorolac — DRUG
    Patients will be randomized to either Ketorolac or Oxycodone

Study Details

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.

Key Dates

Start date
Jul 15, 2025
Status verified
May 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oxycodone- Narcotic
    Arm 1
  • Placebo Comparator: Ketorolac
    Arm 2

Primary Outcome Measure

Primary outcome [ Time Frame: 30 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Coral SpringsCoral SpringsFlorida33067-
Cleveland clinic sports medicineGarfieldOhio44125
Jennifer Baldwin
[email protected]
216.390.5833
Erin Clancy
[email protected]
Kurt Spindler, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicStrongsvilleOhio44136
Jennifer Baldwin
[email protected]
216.390.5833
Erin Clancy
[email protected]
216.970.6796
Kurt Spindler, MD (PRINCIPAL_INVESTIGATOR)

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