Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One minute intercostal nerves cryoanalgesia, Two minutes intercostal nerves cryoanalgesia.
- Who it may be relevant to
- Registry conditions: Pectus Excavatum, Funnel Chest. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
Overview
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
- Procedure One minute intercostal nerves cryoanalgesia
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7 - Procedure Two minutes intercostal nerves cryoanalgesia
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Primary outcome measures
- Postoperative pain level according to Numerical Rating Scale (NRS) [Time frame: 1 week]
Secondary outcome measures (4)
- Opioid consumption [Time frame: 1 week]
- Duration of the surgery [Time frame: 1 day]
- Length of postoperative hospital stay [Time frame: 1 week]
- Occurence of early complications [Time frame: 30 days from the surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- The Children's Memorial Health Institute — Warsaw
Identifiers
NCT: NCT06935799 · 37/KBE/2024