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Clinical Trials/NCT05831137
NCT05831137
Recruiting
Not Applicable

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

Pomeranian Medical University Szczecin1 site in 1 country20 target enrollmentMarch 31, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Funnel Chest
Sponsor
Pomeranian Medical University Szczecin
Enrollment
20
Locations
1
Primary Endpoint
The worse pain occurrence during first 24 hours after operation.
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
July 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pomeranian Medical University Szczecin
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The worse pain occurrence during first 24 hours after operation.

Time Frame: up to 24 hours after operation

numeric pain score, range from 0 to 10

Secondary Outcomes

  • residual wound or chest pain occurrence(postoperative months 1,3)
  • thoracic hypoaesthesia occurrence(up to 24 hours after operation)
  • duration of hospitalization(estimated 4 days)

Study Sites (1)

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