NCT06340932

Impact of Opioid Avoidance Protocol for ACL Reconstruction

Impact of Opioid Avoidance Protocol for ACL Reconstruction Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Matthew Varacallo · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for Anterior Cruciate Ligament Reconstruction (ACLR) postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change. The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in milligrams of morphine equivalent (MME) from postoperative day (POD) 0 to 7 after ACLR compared to the current standard of care pain management protocol. Secondary objectives are to: * evaluate the effects of an opioid avoidance protocol on the daily average numeric rating scale (NRS) pain scores from POD0-7 * evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7 * evaluate the ability to recover opioid free through 7, 30, and 60 days * evaluate the quality of recovery 15 (QoR-15) scores on POD2 * assess the number of opioid prescriptions required by patients in the 60 day recover period * assess Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and symptom scales at 8 weeks post-operatively between groups.

Conditions

• ACL Tear
• Post Operative Pain

Interventions

Type	Name	Description
DEVICE	Iovera	Cryoneurolysis of 5 sensory nerves (Intermediate branch of the AFCN, Medial Femoral Cutaneous Nerve, Suprapatellar branch of the saphenous nerve, 2 branches of the infrapatellar branch of the saphenous nerve) causing Wallerian degeneration
DRUG	Celecoxib	200mg BID
DRUG	Acetaminophen	1000mg q8h
DRUG	Oxycodone	As needed
DRUG	Tramadol	As needed
DRUG	Bupivacaine Hydrochloride	20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK
DRUG	Acetaminophen 500Mg Cap	500mg q6h prn

Timeline

• Start date: 2024-04-27
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-04-02
• Last updated: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study