Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum

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).

Conditions

• Pectus Excavatum
• Pain, Postoperative

Interventions

DEVICE

Use of PCA

A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.

DEVICE

Use of ESB for postoperative pain control after MIRPE

Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.

DEVICE

Use of INC for postoperative pain control after MIRPE

Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.

Sponsors & Collaborators

• Children's Hospital Colorado

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Natasha Corbitt, MD · Safety Officer--University of Texas Southwestern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-05-27

Primary Completion

2026-02-25

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations