Non-Narcotic Pain Control After ACL Reconstruction
The Cleveland Clinic
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.
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 res…
Eligibility
- Age range
- 15–55 years
- Sex
- All
- Healthy volunteers
- No
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 s…
Interventions
- Drugdispense of study drug
• Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen
- DrugKetorolac
Patients will be randomized to either Ketorolac or Oxycodone
Locations (3)
- Cleveland Clinic Coral SpringsCoral Springs, Florida
- Cleveland clinic sports medicineGarfield, Ohio
- Cleveland ClinicStrongsville, Ohio