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Active, Not Recruiting

NCT Number: NCT06973785

Non-Narcotic Pain Control After ACL Reconstruction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

15 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cleveland Clinic Coral Springs, Coral Springs, Florida, United States

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About this study

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 for the pain packet 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 9 oxycodone as rescue medication. For the control group (oxycodone) they will have 9 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dispense of study drug

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

Other names: oxycontin

Ketorolac

Drug

Patients will be randomized to either Ketorolac or Oxycodone

Other names: Toradol

Primary outcomes

  1. Primary outcome

    Time frame: 30 days

    How many narcotic pills were consumed

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 15, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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