Impact of Opioid Avoidance Protocol for ACL Reconstruction

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

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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc

  collaborator INDUSTRY

• Matthew Varacallo

  lead OTHER

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-27

Primary Completion

2025-02-01

Completion

2025-02-01

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations