Funnel ChestFROZEN MIRPENCT07431632
Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)
A study testing Cryotherapy and Epidural in people with Funnel Chest and Pectus Excavatum, run by University of Sao Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Funnel Chest, Pectus Excavatum, Postoperative Pain After Video Assisted Thoracic Surgery
- What is being tested?
- Cryotherapy and Epidural
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Nov 2024to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Having pectus excavatum;
- Having signed the Informed Consent Form for the study.
Who cannot join
- 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;
Show all 9Show fewer
- Hemorrhagic dyscrasia;
- Major anesthetic risk factors or history of previous problems with anesthesia;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School
São Paulo, São Paulo, 05403904
Diego Arley G Silva, MD
Miguel L Tedde, MD, PhD
About this study
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
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).
- Conditions
- Funnel Chest, Pectus Excavatum, Postoperative Pain After Video Assisted Thoracic Surgery, Postoperative Pain
- Being tested
- Cryotherapy, Epidural
- Keywords
- cryoanalgesia, pectus excavatum, funnel chest, postoperative pain, MIRPE
- Medical subject headings
- Funnel Chest, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyDevice
Intraoperative intercostal cryoanalgesia from T3 to T7, billateral
EpiduralProcedure or surgery
Thoracic epidural block
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative intercostal cryoanalgesia | Experimental | Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex Receives: Device: Cryotherapy |
| Thoracic epidural block | Active comparator | Thoracic epidural block Receives: Procedure: Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS)
Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital.
Measured: Perioperative/Periprocedural.
Secondary outcomes (7)
Numeric pain scale
From 0 to 10
Measured: Perioperative/Periprocedural
Opioid use
Oral Morphine Equivalents (OME)
Measured: Perioperative/Periprocedural
Postoperative complications
Surgical complications are registered through an specific scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start28 Nov 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Funnel ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431632
- Sponsor's protocol ID
- 83154924.6.0000.0068
- Acronym
- FROZEN MIRPE
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No