Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure

Regional Analgesia in Combination With Intraoperative Cryoanalgesia Are the Essential Parts of Enhanced Recovery Protocol in the Minimally Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation

Funnel chest deformation is a painful procedure, which requires high doses and long time used of opioids. It makes difficult introduction of ERAS protocol. Intraoperative cryolesia of intercostal nerves serves great relief of pain after this procedures. However ablation of the nerves needs 12-24 hours to achieve effects. During this time the high doses of opioids are needed. It causes side effects (sedation makes rehabilitation difficult). On the other hand, percutaneus cryoablation performed 12-24 hours before Nuss procedure needs repeated general anaesthesia. The investigators hypothesed that regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.

Study Overview

• Status: Recruiting
• Conditions: Acute Pain; Regional Anesthesia
• Intervention / Treatment: Device: regional analgesia with cryolesia

Detailed Description

Severe pain in the post-Nuss procedure needs the use of many analgesic drugs, including opioids. It may cause adverse side effects and difficulties with rehabilitation. Moreover, it increases the risk of complications and prolonged hospitalisation. Cryoanalgesia as a part of multimodal analgesia offers better analgesia than single regional techiques with drugs and fasilitate introduction of the enhanced recovery after surgery (ERAS) protocol. However ablation of the nerves needs 12-24 hours to achieve effects. Regional analgesia (erector spine plain block) performed just before intraopertive cryolesia may cover time to full cryolesia effect.

This Before - After Study is a single institution pilot study designed to compare intraoperative cryolesia alone (control group) with the intervention group (cryolesia and bilateral erector spine plane block). It is designed for better management of acute pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method. Control group received standard care with cryolesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) and multimodal analgesia according the current guidelines. The intervention group received all of the above and regional analgesia (erector spine plain block, ESP block).

The aims of the study were the assessment the effectiveness of ESP block before full action of intraoperative cryoanalgesia as a method of acute pain control, safety of the method.

The results were compared in terms of demographics, pain levels, side effects of the pain relief medications in the postoperative period and lenght of hospitalization.

• Study Type: Interventional
• Enrollment (Anticipated): 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: Sławomir Zacha, MD PhD; Phone Number: 513100813; Email: sekozacha@gmail.com

Study Locations

• Poland
  • Szczecin, Poland, 70-204
    • Recruiting
    • Pomeranian Medical University
    • Contact: Jowita Biernawska, MD PhD; Phone Number: +48501337073; Email: lisienko@wp.pl
  • Szczecin, Poland, 71-252
    • Recruiting
    • Pomeranian Medical University
    • Contact: Jowita Biernawska, MD PhD; Phone Number: +48501337073; Email: lisienko@wp.pl
    • Contact: Sławomir Zacha, MD PhD; Phone Number: +48513100813; Email: sekozacha@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child, 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 up to 18
• informed consent signed for cryoanalgesia informed consent signed for regional analgesia

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: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; intraoperative cryoanalgesia of intercostal nerves with multimodal analgesia
Experimental: intervention; regional analgesia (ESP block) with intraoperative cryoanalgesia of intercostal nerves and multimodal analgesia	Device: regional analgesia with cryolesia; The regional analgesia (erector spine plane block) will be added to intraoperative cryolesia of intercostal nerves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The worse pain	Maximal pain within first 24 hours after operation, Numeric pain score. Range from 0 to 10.	within first 24 hours after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LAST (Local anesthetic systemic toxicity)	No score exists. Assesment of clinical features: sensory and visual changes, muscular activation, seizure activity, new rhythm disturbances.	within first 24 hours after operation

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Investigators: Principal Investigator: Jowita Biernawska, MD PhD, Pomeranian Medical Universitet Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: nuss procedure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: PomeranianMU-KRIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: after contact with the principal investigator

Drug and device information, study documents

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