Cryoanalgesia Aplication Time Optimization During Nuss Procedure

Study Overview
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Brief Summary
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This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.

Detailed Description
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Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain. 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.

Official Title
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The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure

Conditions
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Funnel Chest, Excavatum, Pectus

Intervention / Treatment
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* Procedure: shorter cryoanalgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique informed concent signed for cryolesia Exclusion Criteria: age 9 years or below refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: In each patient one side of the chest will be treated by standard metod and the second side will be treated with the novel method.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention side<br>duration of intercostal nerves cryolesia: 1 minute per left nerve | Procedure: shorter cryoanalgesia<br>* duration time of cryoanalgesia<br>|
| No Intervention: control side<br>duration of intercostal nerves cryolesia: 2 minute per right nerve | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The worse pain occurrence during first 24 hours after operation. | numeric pain score, range from 0 to 10 | up to 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thoracic hypoaesthesia occurrence | cold test assessment (yes / no) | up to 24 hours after operation | 
| residual wound or chest pain occurrence | the chest or wound chronic pain occurrence | postoperative months 1,3 | 
| duration of hospitalization | the lengh of the time in days spent in the hospital | estimated 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nuss procedure, cryoanalgesia