RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2020-05-27
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04211935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * All patients with a pectus excavatum deformity that will undergo a MIRPE procedure will be included in the study.
  1. * \< 13 years old
  2. * \> 18 years old
  3. * chronic narcotic preoperative use
  4. * previous repair of pectus excavatum deformity
  5. * previous thoracic surgery
  6. * pregnancy

Contacts and Locations

Study Contact

Jose L Diaz-Miron, MD
CONTACT
720-777-6571
jose.diaz-miron@childrenscolorado.org

Principal Investigator

Natasha Corbitt, MD
STUDY_DIRECTOR
Safety Officer--University of Texas Southwestern

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-27
Study Completion Date2024-06

Study Record Updates

Study Start Date2020-05-27
Study Completion Date2024-06

Terms related to this study

Additional Relevant MeSH Terms

  • Pectus Excavatum
  • Pain, Postoperative