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Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.
This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One minute cryoanalgesia | Experimental |
| |
| Two minutes cryoanalgesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One minute intercostal nerves cryoanalgesia | Procedure | One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain level according to Numerical Rating Scale (NRS) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | 1 week | |
| Duration of the surgery | 1 day | |
| Length of postoperative hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Memorial Health Institute | Recruiting | Warsaw | Wybierz Województwo | 02-829 | Poland |
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| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
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| Two minutes intercostal nerves cryoanalgesia | Procedure | Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7 |
|
| 1 week |
| Occurence of early complications | 30 days from the surgery |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |