The Use of Video-assisted Intercostal Nerve Cryoablation, Erector Spinae Block, and Thoracic Epidural for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: t
View:

• All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study.

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Jose L Diaz-Miron, MD
jose.diaz-miron@childrenscolorado.org
720-777-6571
Time Frame
Start Date: 2020-05-27
Estimated Completion Date: 2024-06
Participants
Target number of participants: 158
Treatments
Experimental: Patient Controlled Analgesia
This technique involves connecting a patient controlled analgesia pump to the intravenous line. The patient has the ability to push a button to obtain a predetermined dose of an intravenous opioid with a set lockout time period to minimize the potential for over sedation. PCA pumps will be connected to the intravenous line of the patient at the end of the MIRPE operation. anesthesiologists with experience in regional anesthesia.
Experimental: Erector Spinae Block
This method consists of the anesthesiologist placing two catheters on each side of the vertebrae which then delivers pain medicine continuously via pumps for 2-3 days post-surgery.
Experimental: Intercostal Nerve Cryoablation
The INC technique relies on multilevel freezing of the intercostal neurovascular bundle intraoperatively to block sensation and pain for approximately 2 months postoperatively. Trained pediatric surgeons will perform the INC at the time of a MIRPE procedure.
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital Colorado
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov