Cryoanalgesia Aplication Time Optimization During Nuss Procedure

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

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.

Study Overview

• Status: Recruiting
• Conditions: Funnel Chest; Excavatum, Pectus
• Intervention / Treatment: Procedure: shorter cryoanalgesia

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jowita Biernawska, MD PhD; Phone Number: +48501337073; Email: lisienko@wp.pl
• Study Contact Backup: Name: Slawomir Zacha, MD PhD; Phone Number: +48513100813; Email: sekozacha@gmail.com

Study Locations

• Poland
  • Szczecin, Poland, 71-252
    • Recruiting
    • Pomeranian Medical University
    • Contact: Sławomir Zacha, MD PhD; Phone Number: +48513100813; Email: sekozacha@gmail.com
    • Contact: Jowita Biernawska, MDPhD; Phone Number: 501337073; Email: lisienko@wp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Investigators: Study Director: Jowita Biernawska, MD PhD, Pomeranian Medical Universitet Szczecin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Anticipated): June 10, 2023
• Study Completion (Anticipated): July 10, 2023

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cryoanalgesia; nuss procedure
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: PUM NUSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We invite others researchers to collaboration as multicenter study
• IPD Sharing Time Frame: up to 12 months from the beginning of the study
• IPD Sharing Access Criteria: by contacy to the Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No