Non-Narcotic Pain Control After ACL Reconstruction

NeuroTherapia, Inc.

Status and phase: Enrolling; Phase 3

Conditions: ACL Injuries; ACL - Anterior Cruciate Ligament Rupture

Treatments: Drug: Ketorolac; Drug: dispense of study drug

Study type: Interventional

Funder types: Other

Identifiers

NCT06973785

24-1207

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 15 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Oxycodone- Narcotic

Active Comparator group

Description:

Arm 1

Treatment:

Drug: Ketorolac

Ketorolac

Placebo Comparator group

Description:

Arm 2

Treatment:

Drug: dispense of study drug