Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure

NCT07290582 | Completed

• 1 other identifier: EPIC PHABULA
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational ambispective study is to compare the effectiveness of two pain management strategies in pediatric patients undergoing the Nuss procedure for pectus excavatum. The main questions it aims to answer are: Does the addition of phrenic Infiltration as Cryo Adjuvant (PhICA) to earlier percutaneous intercostal cryoanalgesia (EPIC) reduce postoperative pain scores compared to EPIC alone? Does the combined EPIC + PhICA technique reduce the need for rescue tramadol compared to EPIC alone? Do the two approaches differ in: length of hospital stay, time to transition to oral therapy, and time to mobilization? Are there any side effects Researchers will compare patients who received EPIC alone to patients who received EPIC + PhICA to see if the combined technique provides superior pain control. Participants: Received either EPIC alone or EPIC combined with PhICA as part of their surgical anesthesia plan Had pain levels assessed using the Numeric Rating Scale (NRS) at regular postoperative intervals Were monitored for rescue tramadol requirements, medicaments taken, length of hospital stay, and mobilization timing Were monitored for any technique-related complication

Conditions

Pectus Excavatum; Cryo Analgesia; Phrenic Nerve-related Diaphragmatic Impairment

Keywords

cryoanalgesia pectus phrenic

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  NRS scores of patients collected in the medical charts after surgery AND opioids consumption. For each patient, the median and the maximum pain score for each period of the day \[morning (5:01-13:00) afternoon (13:01-21:00) and night (21:01-05:00)\] will be computed and used as pain descriptors for statistical analyses. Opioids will be translated in morphine equivalents through validated tables.

  From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.

Secondary Outcomes (2)

• Time to mobilization after surgery

  From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.

• Length of hospital stay

  From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.

Other Outcomes (1)

• Early Anesthetic related Complications

  postoperatively, From awakening up to 24 hours postoperatively, when the phrenic infiltration shows its effect before wearing off.

Study Arms (2)

EPIC

patients treated with preoperative Earlier Percutaneous Intercostal Cryoneurolysis, from 2 to 7 days prior of surgery and postoperative systemic analgesia protocol.

PhICA

patients were treated with the same preoperative and postoperative protocol as EPIC, but adding a Phrenic Infiltration as Cryo Adjuvant, with low concentration local anesthetic, immediately after surgery and before awakening.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents and young adults with pectus excavatum undergoing the Nuss procedure for its correction

You may qualify if:

• patients who undergo minimally invasive repair at the pediatric surgery department of our referral tertiary center

You may not qualify if:

• patients who refuse OR whose parents refuse to participate in the study

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Sc Ricerca Clinica, Sviluppo E Innovazione

Bergamo, BG, 24100, Italy

Location

Related Publications (3)

• Hung YA, Sun CK, Chiang MH, Chen JY, Ko CC, Chen CC, Chen Y, Teng IC, Hung KC. Effect of Intraoperative Phrenic Nerve Infiltration on Postoperative Ipsilateral Shoulder Pain After Thoracic Surgeries: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3334-3343. doi: 10.1053/j.jvca.2022.04.016. Epub 2022 Apr 15.

  PMID: 35570082 BACKGROUND

• Blichfeldt-Eckhardt MR, Laursen CB, Berg H, Holm JH, Hansen LN, Ording H, Andersen C, Licht PB, Toft P. A randomised, controlled, double-blind trial of ultrasound-guided phrenic nerve block to prevent shoulder pain after thoracic surgery. Anaesthesia. 2016 Dec;71(12):1441-1448. doi: 10.1111/anae.13621. Epub 2016 Sep 16.

  PMID: 27634451 BACKGROUND

• Mariconti S, Bronco A, Pellicioli I, Chiudinelli L, Cattaneo M, Cheli M, Bonanomi E. Earlier preoperative percutaneous intercostal cryoanalgesia improves recovery after pectus excavatum surgery. Reg Anesth Pain Med. 2026 Feb 5;51(2):200-207. doi: 10.1136/rapm-2024-105960.

  PMID: 39510802 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

• Ezio Bonanomi, MD

  papa Giovanni XXIII Hospital - Bergamo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medicine Doctor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 18, 2025
• Study Start: September 14, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 15, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

IT (1)