Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

NCT06935799 | Recruiting

• 1 other identifier: 37/KBE/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications. This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.

Conditions

Pectus Excavatum; Funnel Chest

Keywords

cryoanalgesia; pain management; pectus excavatum; funnel chest

Outcome Measures

Primary Outcomes (1)

• Postoperative pain level according to Numerical Rating Scale (NRS)

  1 week

Secondary Outcomes (4)

• Opioid consumption

  1 week

• Duration of the surgery

  1 day

• Length of postoperative hospital stay

  1 week

• Occurence of early complications

  30 days from the surgery

Study Arms (2)

One minute cryoanalgesia

EXPERIMENTAL

Procedure: One minute intercostal nerves cryoanalgesia

Two minutes cryoanalgesia

ACTIVE COMPARATOR

Procedure: Two minutes intercostal nerves cryoanalgesia

Interventions

One minute intercostal nerves cryoanalgesia PROCEDURE

One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

One minute cryoanalgesia

Two minutes intercostal nerves cryoanalgesia PROCEDURE

Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7

Two minutes cryoanalgesia

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pectus excavatum repair with MIRPE
• Written consent for corrective surgery with intraoperative cryoanalgesia
• Written consent to participate in the study
• Age \>12 and \< 18 years

You may not qualify if:

• History of previous thoracic surgeries
• Reoperation for chest deformity
• Contraindication for cryoanalgesia
• Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead

Study Sites (1)

The Children's Memorial Health Institute

Warsaw, Wybierz Województwo, 02-829, Poland

RECRUITING

MeSH Terms

Conditions

Funnel Chest; Agnosia

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Pediatric Surgery and Organ Transplantation, CMHI

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 20, 2025
• Study Start: April 25, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-03

Locations

PL (1)