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Clinical trial Recruiting at 1 site Interventional Ages 13 and up

Intraoperative cryoanalgesia versus thoracic epidural block for pain control after minimally invasive pectus excavatum repair

Official 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

Run by University of Sao Paulo · NCT07431632 · Data updated 2026-11-12

This trial will try intraoperative cryoanalgesia versus a thoracic epidural block to see which controls pain better after minimally invasive pectus excavatum repair in patients aged 13 and older.

More Postoperative Pain trials

Quick facts

Study typeInterventional
Ages13 Years and up
SexAll
Enrollment40 (estimated)
SponsorUniversity of Sao Paulo
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedNovember 28, 2024
Main results expectedJanuary 2027
Study endsJanuary 2028
Registry record updatedFebruary 24, 2026
Trial IDNCT07431632 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 13 years or older with pectus excavatum who are scheduled for minimally invasive repair and who have no prior thoracic surgery or major anesthetic contraindications and who can give informed consent.

Probably not a fit

Patients younger than 13, those with prior pectus repairs or thoracic surgery, chronic preoperative analgesic use, chest wall anomalies like pectus carinatum or Poland syndrome, major anesthetic risks, congenital heart disease, bleeding disorders, or pregnancy are unlikely to benefit from enrollment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares two intraoperative pain-control techniques for patients undergoing minimally invasive repair of pectus excavatum (MIRPE): cryoanalgesia of the intercostal nerves and thoracic epidural blockade. Participants who meet inclusion criteria receive one of the two analgesic approaches at the time of surgery and are followed for postoperative pain outcomes and analgesic use. Key exclusions include age under 13, prior thoracic surgery or pectus repair, chronic preoperative analgesic use, congenital heart disease, bleeding disorders, major anesthetic risks, and pregnancy. The study is conducted at the Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School in São Paulo, Brazil.

Why it matters

Potential benefit: If successful, the cryoanalgesia approach could provide equally good or better postoperative pain control with reduced opioid needs and fewer epidural-related complications.

How similar studies have gone: Small case series and observational studies suggest cryoanalgesia can reduce postoperative pain and opioid use after thoracic procedures, but randomized evidence specifically in MIRPE is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School
    São Paulo, São Paulo, Brazil     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.