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
- Are there results?
- Not yet: the study is under way
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;
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- 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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07431632
- Acronym / sponsor ID
- FROZEN MIRPE / 83154924.6.0000.0068
- Conditions
- Funnel Chest, Pectus Excavatum, Postoperative Pain After Video Assisted Thoracic Surgery, Postoperative Pain
- Keywords
- cryoanalgesia, pectus excavatum, funnel chest, postoperative pain, MIRPE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative intercostal cryoanalgesia | Experimental | Device: CryotherapyIntercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex |
| Thoracic epidural block | Active comparator | Procedure: EpiduralThoracic epidural block |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Having pectus excavatum;
- Having signed the Informed Consent Form for the study.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyIntraoperative intercostal cryoanalgesia from T3 to T7, billateral | Device | Intraoperative intercostal cryoanalgesia |
| EpiduralThoracic epidural block | Procedure or surgery | Thoracic epidural block |
Primary outcome
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.
7 secondary outcomes
Numeric pain scale
Time frame: Perioperative/Periprocedural
Opioid use
Time frame: Perioperative/Periprocedural
Postoperative complications
Time frame: 30 days post-surgery.
Readmissions to the emergency room or hospital readmission
Time frame: Within 30 days after surgery
Frequency of neuropathic pain
Time frame: Up to 1 year post-surgery.
Satisfaction with the post-operative result
Time frame: Single evaluation during the outpatient follow-up 6 months after surgery.
Cost of hospitalization (in Brazilian Real)
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miguel L Tedde, MD, PhD (55-11-99653-5030, tedde@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) (time frame: Perioperative/Periprocedural.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.