The Effect of Pre-Operative Cryoneurolysis on Post-Operative Narcotic Consumption in Patients Undergoing Autograft ACL Reconstruction

Conditions

• ACL Repair

Eligibility Criteria

Sex

ALL

Age

14 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cryoneurolysis — PROCEDURE
  Those randomized to the intervention group (Group B) will receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days of their scheduled surgery. Treatment nerves for the procedure will include the anterior femoral cutaneous nerve (AFCN), supra-patellar branch of the saphenous nerve (SPBSN) and infra-patellar branch of the saphenous nerve (IPBSN).

Study Details

The purpose of the research is to investigate the effect of preoperative Cryoneurolysis of the knee on postoperative pain management in patients undergoing autograft anterior cruciate ligament (ACL) reconstruction (a surgical procedure that makes a new ACL using the patient's own tendon). Cryoneurolysis is an approved process of applying extreme cold temperatures to targeted nerves in order to decrease or eliminate pain. . If you take part in the research, you will be randomly assigned (assigned by chance, like a flip of a coin) to Group A (standard care) or Group B (standard care plus Cryoneurolysis). Participants in both groups will undergo standard ACL reconstruction and receive standard preoperative and postoperative pain management. Participants in Group B only will also receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days before their scheduled surgery. Participants in both groups (A \& B) will be asked to bring their remaining postoperative pain medication to their postoperative follow-up appointments for review by study personnel. Participants will also be asked to complete a survey about their knee activity, function and symptoms at these appointments. Your time in the study will last until the completion of the 12-week postoperative follow-up appointment.

Key Dates

Start date

Aug 28, 2024

Status verified

May 2026

Primary completion

Apr 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Arm A: ACL reconstruction usual care
  On the day of surgery, all patients (Group A and Group B) will receive a multi-modal oral pre-operative cocktail and an ultrasound guided adductor canal block. Additionally, an ultrasound guided popliteal or infiltration of the tissue plane between the popliteal artery and the capsule of the knee (iPACK) block will be administered. The pre-operative oral medication cocktail and block medications are as follows: Acetaminophen 975 mg x 1, Celecoxib 400 mg PO x 1, adductor canal block with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL), popliteal or iPACK nerve infiltration with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL). 15 mg IV ketorolac at conclusion of the case will be administered.
• Experimental: Arm B: Usual care plus pre-operative cryoneurolysis
  Those randomized to the intervention group (Group B) will receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days of their scheduled surgery. Treatment nerves for the procedure will include the anterior femoral cutaneous nerve (AFCN), supra-patellar branch of the saphenous nerve (SPBSN) and infra-patellar branch of the saphenous nerve (IPBSN).

Primary Outcome Measure

Post-operative opioid consumption [ Time Frame: Measured at 1-week, 6-weeks, 12-weeks ]

Central Contacts

• Sean Mc Millan, DO
  (609)747-9200
  [email protected]

Locations (2)

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