Cryoanalgesia to Prevent Acute and Chronic Pain Following Nuss Procedure

Cryoanalgesia in Combination With the Novel Prehabilitation Program Back on Feet Are the Essential Parts of Enhanced Recovery Protocol in the Minimal Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation.

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).

Study Overview

• Status: Completed
• Conditions: Funnel Chest; Excavatum, Pectus
• Intervention / Treatment: Device: intercostal nerves cryoanalgesia

Detailed Description

Funnel chest deformation is a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain. The use of many analgesic drugs, including opioids, is associated with adverse side effects, difficulties with rehabilitation, an increased risk of complications, prolonged hospitalisation, and the cost of the procedure. Cryoanalgesia as a part of multimodal analgesia along with the education and prehabilitation of the patient according to the novel original educational - training application 'Back on Feet' as well as the interdisciplinary care in accordance with the enhanced recovery after surgery (ERAS) protocol, which has a real impact on the optimisation of perioperative care.

This Before - After Study is a single institution pilot study designed to compare standard therapy (control group: regional analgesia: intrapleural or bilateral erector spine plane block) versus a novel approach (interventional group: Cryoanalgesia combined with bilateral single shot erector spine plane block) 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.

First group received a standard care according to Polish guidelines. The data of control group analysed and the interdisciplinary team work protocol will be introduced to the interventional group. The interventional group was prepared according to prehabilitation with the 'Back on feet' application and perioperative ERAS protocols. The patients of interventional group received intraoperative cryoanalgesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) as an additional procedure to multimodal analgesia. This is the first time that the cryoanalgesia procedure was performed in children in Poland.

The aims of the study were the assessment the effectiveness of cryoanalgesia as a method of acute and long-term pain control, safety of the method and the impact of preoperative preparation according to the 'Back on Feet' program introduced as a part of ERAS protocol.

Specific Aim 1: To determine if, compared with current analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain.

Hypothesis 1a (primary): The severity of surgically-related pain was significantly decreased from postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.

Hypothesis 1b: The incidence and severity of chronic pain was significantly decreased 3 months following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.

Specific Aim 2: To determine if, compared with current analgesia, the addition of cryoanalgesia improves postoperative functioning.

Hypothesis 2a: Following modyfied Nuss procedure the range of motion and independence was significantly increased in the 2 postoperative day following operation with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.

The results were compared in terms of demographics, pain levels, side effects of the pain relief medications in the postoperative period, quality and length of rehabilitation, patient satisfaction using the Quality of Life by modyfied Nuss questionnaire, and the total costs of hospitalization.

• Study Type: Interventional
• Enrollment (Actual): 40
• 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
    • Pomeranian Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
• aged 10 years or above 10
• informed consent signed for cryoanalgesia

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: "the before" group; Control group as a standard therapy in Poland (regional analgesia: intrapleural or bilateral erector spine plane block added to multimodal analgesia).
Experimental: "the after" group; 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; Intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic consumption post operation	Total analgesic (including opioids) consumption for previous 24 hours	Postoperative days 0, 1, 2, 3, 4, 5,6, as well as months 1 and 3
Thoracic hypo-aesthesia occurence	Cold test assessment (Yes/No)	up to 24 hours after operation
Assessment of sleeping quality	Collect difficulties of sleeping due to pain? (binary answer: yes or no; not based on a scale or instrument)	Postoperative days 1, 2, 3, 4, 5 ,6
Postoperative nausea and vomiting (PONV) occurence	binary answer: yes or no; not based on a scale or instrument	Postoperative days 1, 2, 3, 4, 5 ,6
Residual wound or chest pain occurence	The chest or wound chronic pain occurrences	Postoperative months 1, 3
Total narcotic use post-operation	Total dose and number of days of opioids used during hospitalization	0-6 postoperative days
Cost Analysis	total costs of hospitalization	estimated 1 week
Duration of hospitalization	the length of the time (in days) spent in the hospital	estimated 1 week

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

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): December 10, 2022

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

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

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 contact to 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