Clinical trial NCT06973785: Non-Narcotic Pain Control After ACL Reconstruction
Official title: Non-Narcotic Pain Control After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ACL - Anterior Cruciate Ligament Rupture
ACL Injuries
Keywords: acl
Narcotic use
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: Cleveland Clinic Coral Springs
state: Florida
city: Garfield
country: United States
facility: Cleveland clinic sports medicine
state: Ohio
city: Strongsville
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kurt P Spindler, MD
role: PRINCIPAL_INVESTIGATOR
References: