Cryoanalgesia Aplication Time Optimization During Nuss Procedure
NCT ID: NCT05831137
Last Updated: 2023-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2023-03-31
2023-07-10
Brief Summary
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Detailed Description
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2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.
This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.
All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).
The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).
The study will assess the effectiveness of shorter aplication duration time of cryoanalgesia as a method of acute and long-term pain control and safety of the method.
Specific Aim: To determine if, compared with current 2 minutes cryoanalgesia protocol, 1 minute aplication time of cryoanalgesia is effective at the same level when consider pain control and postoperative functioning in each patient.
The results were compared in terms of demographics, right versus left side of the chest pain levels, quality and length of rehabilitation and patient satisfaction using the Quality of Life by modyfied Nuss questionnaire.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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intervention side
duration of intercostal nerves cryolesia: 1 minute per left nerve
shorter cryoanalgesia
duration time of cryoanalgesia
control side
duration of intercostal nerves cryolesia: 2 minute per right nerve
No interventions assigned to this group
Interventions
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shorter cryoanalgesia
duration time of cryoanalgesia
Eligibility Criteria
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Inclusion Criteria
* informed concent signed for cryolesia
Exclusion Criteria
* refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
10 Years
ALL
No
Sponsors
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Pomeranian Medical University Szczecin
OTHER
Responsible Party
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Principal Investigators
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Jowita Biernawska, MD PhD
Role: STUDY_DIRECTOR
Pomeranian Medical Universitet Szczecin
Locations
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Pomeranian Medical University
Szczecin, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Zeineddin S, Goldstein SD, Linton S, DeBoer C, Alayleh A, Ortiz I, Sands L, Kujawa S, Suresh S, Ghomrawi H, Abdullah F. Effectiveness of one minute per level intercostal nerve cryoablation for postoperative analgesia after surgical correction of pectus excavatum. J Pediatr Surg. 2023 Jan;58(1):34-40. doi: 10.1016/j.jpedsurg.2022.09.032. Epub 2022 Sep 26.
Other Identifiers
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PUM NUSS
Identifier Type: -
Identifier Source: org_study_id
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