Cryoanalgesia Aplication Time Optimization During Nuss Procedure

Funnel Chest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05831137
• Other study ID #: PUM NUSS
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: March 2023
• Source: Pomeranian Medical University Szczecin
• Contact: Jowita Biernawska, MD PhD
• Phone: +48501337073
• Email: lisienko[@]wp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 10, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Excavatum, Pectus
• Funnel Chest

Intervention

Procedure:
• shorter cryoanalgesia
duration time of cryoanalgesia

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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 ex — View Citation

Outcome

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