ACL - Anterior Cruciate Ligament Rupture, ACL Injuries
Conditions
Keywords
acl, Narcotic use
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 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.
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
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 15-55 years 4. Primary Autograft ACL surgery 5. Ability to take oral medication and willingness to patriciate in a virtual 1 week follow-up pill count visit
Exclusion criteria
1\. Any extensor mechanism dislocation or disruption 2. Multi-ligament injury that requires repair 3. Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control 4. Psychiatric illness that impedes evaluation of pain and/or narcotics use 5. History of Chronic Kidney Disease 6. History of inflammatory arthritis, diabetes, or autoimmune disease 7. History of GI bleed or documented GI ulcer (diagnosed by endoscopy) 8. Allograft or revision of ACLR 9. Contraindications to ketorolac or opioids \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 30 days | How many narcotic pills were consumed |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKurt P Spindler, MD
The Cleveland Clinic
Outcome results
None listed