Funnel Chest, Pectus Excavatum, Postoperative Pain, Postoperative Pain After Video Assisted Thoracic Surgery
Conditions
Keywords
cryoanalgesia, pectus excavatum, funnel chest, postoperative pain, MIRPE
Brief 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).
Interventions
DEVICECryotherapy
Intraoperative intercostal cryoanalgesia from T3 to T7, billateral
PROCEDUREEpidural
Thoracic epidural block
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay (LOS) | Perioperative/Periprocedural. | Length of stay (LOS) is measured in days from postoperative day (POD) 0 until discharge from hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric pain scale | Perioperative/Periprocedural | From 0 to 10 |
| Opioid use | Perioperative/Periprocedural | Oral Morphine Equivalents (OME) |
| Postoperative complications | 30 days post-surgery. | Surgical complications are registered through an specific scale. |
| Readmissions to the emergency room or hospital readmission | Within 30 days after surgery | Compare the frequency and reason for readmissions to the emergency room or hospital admission between groups. |
| Frequency of neuropathic pain | Up to 1 year post-surgery. | 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. |
| Satisfaction with the post-operative result | Single evaluation during the outpatient follow-up 6 months after surgery. | 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. |
| Cost of hospitalization (in Brazilian Real) | Perioperative/Periprocedural | Compare the total cost of hospitalization during the hospital stay between the two groups. |
Countries
Brazil
Contacts
CONTACTMiguel L Tedde, MD, PhD
CONTACTDiego Arley G Silva, MD
Outcome results
None listed