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

Comparative Study of the Efficacy of Intraoperative Intercostal Cryoanalgesia and Thoracic Epidural Block in the Postoperative Period of Minimally Invasive Pectus Excavatum Repair (MIRPE): a Prospective, Randomized Clinical Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Funnel Chest; Pectus Excavatum; Postoperative Pain After Video Assisted Thoracic Surgery
• Intervention / Treatment: Device: Cryotherapy; Procedure: Epidural

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel L Tedde, MD, PhD; Phone Number: 55-11-99653-5030; Email: tedde@usp.br
• Study Contact Backup: Name: Diego Arley G Silva, MD; Phone Number: 55-83-98650-6438; Email: diegoarley@usp.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403904
      • Recruiting
      • Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School
      • Principal Investigator: Miguel L Tedde, MD, PhD
      • Sub-Investigator: Diego Arley G Silva, MD
      • Sub-Investigator: Paulo Manuel Pego-Fernandes, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative intercostal cryoanalgesia; Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex	Device: Cryotherapy; Intraoperative intercostal cryoanalgesia from T3 to T7, billateral
Active Comparator: Thoracic epidural block	Procedure: Epidural; Thoracic epidural block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay (LOS)	Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.	Perioperative/Periprocedural.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain scale	From 0 to 10	Perioperative/Periprocedural
Opioid use	Oral Morphine Equivalents (OME)	Perioperative/Periprocedural
Postoperative complications	Surgical complications are registered through an specific scale.	30 days post-surgery.
Readmissions to the emergency room or hospital readmission	Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups.	Within 30 days after surgery
Frequency of neuropathic pain	Incidence of chronic neuropathic pain and paresthesia up to 1 year post-surgery in the group undergoing intercostal cryoablation, using LANNS (Leeds assessment of Neuropathic Symptoms and Signs) scale.	Up to 1 year post-surgery.
Satisfaction with the post-operative result	Compare patient-reported experience measures (PREMs) between the intercostal cryoablation and thoracic epidural block groups based on postoperative satisfaction at 6 months, assessed using the Single Step Questionnaire (SSQ) score.	Single evaluation during the outpatient follow-up 6 months after surgery.
Cost of hospitalization (in Brazilian Real)	Compare the total cost of hospitalization during the hospital stay between the two groups.	Perioperative/Periprocedural

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: postoperative pain; pectus excavatum; cryoanalgesia; funnel chest; MIRPE
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Funnel Chest; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Spinal; Cryotherapy; Injections, Epidural
• Other Study ID Numbers: 83154924.6.0000.0068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No