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

NCT04211935 | Active Not Recruiting FDA Device

• 1 other identifier: 19-2794
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Length of Stay

  The investigators will measure the total length of stay following the operation until discharge from the hospital.

  24 months

Secondary Outcomes (4)

• Total intravenous and oral opioid use

  24 months

• Postoperative pain

  24 months

• Quality of life after MIRPE

  24 months

• Complications

  24 months

Study Arms (3)

Patient Controlled Analgesia

EXPERIMENTAL

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.

Device: Use of PCA

Erector Spinae Block

EXPERIMENTAL

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.

Device: Use of ESB for postoperative pain control after MIRPE

Intercostal Nerve Cryoablation

EXPERIMENTAL

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.

Device: Use of INC for postoperative pain control after MIRPE

Interventions

Use of PCA DEVICE

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

Patient Controlled Analgesia

Use of ESB for postoperative pain control after MIRPE DEVICE

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

Erector Spinae Block

Use of INC for postoperative pain control after MIRPE DEVICE

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

Intercostal Nerve Cryoablation

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \< 12 years old
• \> 21 years old
• chronic narcotic preoperative use
• previous repair of pectus excavatum deformity
• previous thoracic surgery
• pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Funnel Chest; Pain, Postoperative

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Natasha Corbitt, MD

  Safety Officer--University of Texas Southwestern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomly assigned to one of three interventional groups. Study participants and team members will be blinded on randomized group until entering the operating room, at which point the cryoablation machine and instruments will be brought into the room for INC or the anesthesiologist will place ESB. The PCA pump will be connected to the patient's intravenous line at the end of the case.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: May 27, 2020
• Primary Completion: February 25, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)