Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)

NCT07431632 | Recruiting

• 1 other identifier: 83154924.6.0000.0068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).

Conditions

Funnel Chest; Pectus Excavatum; Postoperative Pain After Video Assisted Thoracic Surgery; Postoperative Pain

Keywords

cryoanalgesia; pectus excavatum; funnel chest; postoperative pain; MIRPE

Outcome Measures

Primary Outcomes (1)

• Length of stay (LOS)

  Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.

  Perioperative/Periprocedural.

Secondary Outcomes (7)

• Numeric pain scale

  Perioperative/Periprocedural

• Opioid use

  Perioperative/Periprocedural

• Postoperative complications

  30 days post-surgery.

• Readmissions to the emergency room or hospital readmission

  Within 30 days after surgery

• Frequency of neuropathic pain

  Up to 1 year post-surgery.

Study Arms (2)

Intraoperative intercostal cryoanalgesia

EXPERIMENTAL

Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex

Device: Cryotherapy

Thoracic epidural block

ACTIVE COMPARATOR

Thoracic epidural block

Procedure: Epidural

Interventions

Cryotherapy DEVICE

Intraoperative intercostal cryoanalgesia from T3 to T7, billateral

Intraoperative intercostal cryoanalgesia

Epidural PROCEDURE

Thoracic epidural block

Thoracic epidural block

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having pectus excavatum;
• Having signed the Informed Consent Form for the study.

You may not qualify if:

• Age \< 13 years at the time of the procedure;
• Chronic use of analgesics preoperatively;
• Pectus carinatum, Poland syndrome, or other chest wall anomalies;
• Previous pectus excavatum repair by any technique;
• Previous thoracic surgery;
• Congenital heart disease;
• Hemorrhagic dyscrasia;
• Major anesthetic risk factors or history of previous problems with anesthesia;
• Pregnancy.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School

São Paulo, São Paulo, 05403904, Brazil

RECRUITING

MeSH Terms

Conditions

Funnel Chest; Pain, Postoperative

Interventions

Cryotherapy; Injections, Epidural

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

Intervention Hierarchy (Ancestors)

Therapeutics; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy

Central Study Contacts

Miguel L Tedde, MD, PhD

CONTACT

55-11-99653-5030; tedde@usp.br

Diego Arley G Silva, MD

CONTACT

55-83-98650-6438; diegoarley@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 24, 2026
• Study Start: November 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

BR (1)