Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative intercostal cryoanalgesia | Experimental | Intercostal nerve cryoanalgesia with the Cryo-S Painless device from Metrum Cryoflex |
|
| Thoracic epidural block | Active Comparator | Thoracic epidural block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Device | Intraoperative intercostal cryoanalgesia from T3 to T7, billateral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay (LOS) | Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital. | Perioperative/Periprocedural. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain scale | From 0 to 10 | Perioperative/Periprocedural |
| Opioid use | Oral Morphine Equivalents (OME) | Perioperative/Periprocedural |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel L Tedde, MD, PhD | Contact | 55-11-99653-5030 | tedde@usp.br | |
| Diego Arley G Silva, MD | Contact | 55-83-98650-6438 | diegoarley@usp.br |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Division, Heart Institute (InCor), University of Sao Paulo Medical School | Recruiting | São Paulo | São Paulo | 05403904 | Brazil |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2025 | Feb 18, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Epidural | Procedure | Thoracic epidural block |
|
| Postoperative complications | Surgical complications are registered through an specific scale. | 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. | 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. | 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. | 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. | Perioperative/Periprocedural |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent form | Mar 8, 2024 | Feb 18, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
Not provided
Not provided