Intraoperative cryoanalgesia versus thoracic epidural block for pain control after minimally invasive pectus excavatum repair
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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07431632 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
São Paulo, São Paulo
- Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Miguel L Tedde, MD, PhD
- Email: tedde@usp.br
- Phone: 55-11-99653-5030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.