Cryoanalgesia Aplication Time Optimization During Nuss Procedure

NCT05831137 | Unknown DMC

• 1 other identifier: PUM NUSS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Funnel Chest; Excavatum, Pectus

Keywords

nuss procedure; cryoanalgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• thoracic hypoaesthesia occurrence

  up to 24 hours after operation

• residual wound or chest pain occurrence

  postoperative months 1,3

• duration of hospitalization

  estimated 4 days

Study Arms (2)

intervention side

EXPERIMENTAL

duration of intercostal nerves cryolesia: 1 minute per left nerve

Procedure: shorter cryoanalgesia

control side

NO INTERVENTION

duration of intercostal nerves cryolesia: 2 minute per right nerve

Interventions

shorter cryoanalgesia PROCEDURE

duration time of cryoanalgesia

intervention side

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
• informed concent signed for cryolesia

You may not qualify if:

• age 9 years or below
• refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 71-252, Poland

RECRUITING

Related 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 excavatum. J Pediatr Surg. 2023 Jan;58(1):34-40. doi: 10.1016/j.jpedsurg.2022.09.032. Epub 2022 Sep 26.

  PMID: 36283847 RESULT

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jowita Biernawska, MD PhD

  Pomeranian Medical Universitet Szczecin

  STUDY DIRECTOR

Central Study Contacts

Jowita Biernawska, MD PhD

CONTACT

+48501337073; lisienko@wp.pl

Slawomir Zacha, MD PhD

CONTACT

+48513100813; sekozacha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 26, 2023
• Study Start: March 31, 2023
• Primary Completion: June 10, 2023
• Study Completion: July 10, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: up to 12 months from the beginning of the study
• Access Criteria: by contacy to the Principal Investigator

Locations

PL (1)