Funnel Chest, Pectus Excavatum
Conditions
Keywords
cryoanalgesia, pain management, pectus excavatum, funnel chest
Brief summary
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.
Interventions
PROCEDUREOne minute intercostal nerves cryoanalgesia
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
PROCEDURETwo minutes intercostal nerves cryoanalgesia
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Sponsors
Children's Memorial Health Institute, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pectus excavatum repair with MIRPE * Written consent for corrective surgery with intraoperative cryoanalgesia * Written consent to participate in the study * Age \>12 and \< 18 years
Exclusion criteria
* History of previous thoracic surgeries * Reoperation for chest deformity * Contraindication for cryoanalgesia * Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain level according to Numerical Rating Scale (NRS) | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Opioid consumption | 1 week |
| Duration of the surgery | 1 day |
| Length of postoperative hospital stay | 1 week |
| Occurence of early complications | 30 days from the surgery |
Countries
Poland
Outcome results
None listed