Cryoanalgesia Aplication Time Optimization During Nuss Procedure

Not Applicable

Recruiting

• Conditions: Funnel Chest; Excavatum, Pectus
• Interventions: Procedure: shorter cryoanalgesia

• Registration Number: NCT05831137
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-31
• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-06-10
• Study Completion: 2023-07-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intervention side	shorter cryoanalgesia	duration of intercostal nerves cryolesia: 1 minute per left nerve

Primary Outcome Measures

Name	Time	Method
The worse pain occurrence during first 24 hours after operation.	up to 24 hours after operation	numeric pain score, range from 0 to 10

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Poland