Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft
NYU Langone Health
Summary
The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18-45 years 2. Scheduled for primary ACLR with BPTB autograft 3. Willingness and ability to participate in Iovera 4. No chronic opioid use preoperatively 5. No known neurologic disorders affecting the lower extremity 6. Capacity and willingness to provide informed consent and comply with follow-up schedules Exclusion Criteria: 1. Prior surgery on the affected knee. 2. Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved. 3. Contraindications to cryoneurolysis (e.g., cr…
Interventions
- DevicePacira Iovera Cryoneurolysis device
The device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery.
- DevicePlacebo/Sham device
The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.
Location
- NYU Langone HealthNew York, New York