RecruitingNot ApplicableNCT07431632

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

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

Sponsor

University of Sao Paulo

Enrollment

40 participants

Start Date

Nov 28, 2024

Study Type

INTERVENTIONAL

Conditions

Funnel Chest

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).

Eligibility

Min Age: 13 Years

Inclusion Criteria2

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

Exclusion Criteria9

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.

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Interventions

DEVICECryotherapy

Intraoperative intercostal cryoanalgesia from T3 to T7, billateral

PROCEDUREEpidural

Thoracic epidural block

Locations(1)

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

São Paulo, São Paulo, Brazil

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NCT07431632