Intercostal Nerve Cryoablation for Postoperative Pain Management

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 15, 2019

Primary Completion Date

September 22, 2022

Study Completion Date

September 22, 2022

Conditions
Pain, Postoperative
Interventions
DEVICE

Intercostal Nerve Cryoablation

Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.

DRUG

Bupivacaine liposomal injectable suspension

Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).

DRUG

Patient-controlled analgesia (PCA)

Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER

NCT03972397 - Intercostal Nerve Cryoablation for Postoperative Pain Management | Biotech Hunter | Biotech Hunter