NCT04211935: (MIRPE)

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

Active, enrolled NA Last updated 27 April 2026

What this trial tests

NA trial testing Use of PCA in Pectus Excavatum in 158 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 May 2020

Primary endpoint
25 February 2026

1 December 2027

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	158
Start date	27 May 2020
Primary completion	25 February 2026
Estimated completion	1 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Use of PCA
• Use of ESB for postoperative pain control after MIRPE
• Use of INC for postoperative pain control after MIRPE

Conditions studied

• Pectus Excavatum — all drugs for Pectus Excavatum →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

University of Colorado, Denver

Who can join

Adults 12 to 21, any sex, with Pectus Excavatum or Pain, Postoperative. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Length of Stay
  Time frame: 24 months
  The investigators will measure the total length of stay following the operation until discharge from the hospital.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.