Cryoanalgesia to Prevent Acute and Chronic Pain Following Nuss Procedure

NCT05570097 | Completed DMC

• 1 other identifier: PomeranianMedicalUniveristy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This Study study compared standard therapy (multimodal and regional analgesia) versus a novel approach (Cryoanalgesia combined with bilateral erector spine plane block and multimodal analgesia) in subjects undergoing minimal invasive modyfied Nuss procedure (thoracoscopy).

Conditions

Funnel Chest; Excavatum, Pectus

Keywords

nuss procedure; ERAS; cryolesia; cryoanalgesia

Outcome Measures

Primary Outcomes (1)

• The worse pain occurence during first 24 hours after operation

  Numeric pain score. Range from 0 to 10.

  up to 24 hours after operation

Secondary Outcomes (8)

• Analgesic consumption post operation

  Postoperative days 0, 1, 2, 3, 4, 5,6, as well as months 1 and 3

• Thoracic hypo-aesthesia occurence

  up to 24 hours after operation

• Assessment of sleeping quality

  Postoperative days 1, 2, 3, 4, 5 ,6

• Postoperative nausea and vomiting (PONV) occurence

  Postoperative days 1, 2, 3, 4, 5 ,6

• Residual wound or chest pain occurence

  Postoperative months 1, 3

Study Arms (2)

"the before" group

NO INTERVENTION

Control group as a standard therapy in Poland (regional analgesia: intrapleural or bilateral erector spine plane block added to multimodal analgesia).

"the after" group

EXPERIMENTAL

During modyfied Nuss thoracoscopy the intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.

Device: intercostal nerves cryoanalgesia

Interventions

intercostal nerves cryoanalgesia DEVICE

Intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.

"the after" group

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
• aged 10 years or above 10
• informed consent signed for cryoanalgesia

You may not qualify if:

• Age of 9 years or below
• Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
• Any contraindication to cryoanalgesia
• Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University

Szczecin, 71-252, Poland

Location

Related Publications (1)

• Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.

  PMID: 30935731 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Before - after study: First: control group as a standard treatment in Poland, review, then: interventional group

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 6, 2022
• Study Start: September 28, 2022
• Primary Completion: October 10, 2022
• Study Completion: December 10, 2022
• Last Updated: March 28, 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 contact to Principal Investigator

Locations

PL (1)