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NCT Number: NCT07431632

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

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).

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Key information

Conditions

Funnel Chest Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pectus Excavatum Postoperative Complications Postoperative Pain Postoperative Pain After Video Assisted Thoracic Surgery Signs and Symptoms

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403904, Brazil

Location status: Recruiting

Location contact

Diego Arley G Silva, MD

SUB_INVESTIGATOR

Miguel L Tedde, MD, PhD

PRINCIPAL_INVESTIGATOR

Paulo Manuel Pego-Fernandes, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Cryotherapy

Device

Intraoperative intercostal cryoanalgesia from T3 to T7, billateral

Epidural

Procedure

Thoracic epidural block

Primary outcomes

  1. Length of stay (LOS)

    Time frame: Perioperative/Periprocedural.

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

Secondary outcomes

  1. Numeric pain scale

    Time frame: Perioperative/Periprocedural

    From 0 to 10

  2. Opioid use

    Time frame: Perioperative/Periprocedural

    Oral Morphine Equivalents (OME)

  3. Postoperative complications

    Time frame: 30 days post-surgery.

    Surgical complications are registered through an specific scale.

  4. Readmissions to the emergency room or hospital readmission

    Time frame: Within 30 days after surgery

    Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups.

  5. Frequency of neuropathic pain

    Time frame: Up to 1 year post-surgery.

    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.

  6. Satisfaction with the post-operative result

    Time frame: Single evaluation during the outpatient follow-up 6 months after surgery.

    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.

  7. Cost of hospitalization (in Brazilian Real)

    Time frame: Perioperative/Periprocedural

    Compare the total cost of hospitalization during the hospital stay between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Arley G Silva, MD

CONTACT

[email protected]

55-83-98650-6438

Miguel L Tedde, MD, PhD

CONTACT

[email protected]

55-11-99653-5030

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: FROZEN MIRPE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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