NCT06973785

Non-Narcotic Pain Control After ACL Reconstruction

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 15 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• ACL - Anterior Cruciate Ligament Rupture
• ACL Injuries

Interventions

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

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2025-05-15
• Last updated: 2025-08-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study