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

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

Study Overview

• Status: Completed
• Conditions: Pectus Excavatum; Cryo Analgesia; Phrenic Nerve-related Diaphragmatic Impairment

Detailed Description

This is a retrospective-prospective (ambispective) study as it compares a control group (EPIC) retrospectively reviewed with a prospectively recruited case group of patients (PhICA)

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Italy
  • BG
    • Bergamo, BG, Italy, 24100
      • Sc Ricerca Clinica, Sviluppo E Innovazione

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to mobilization after surgery	We are going to record for analysis the postoperative day (POD) in which all the following activities of daily living items were simultaneously achieved: ambulating, feeding, and toileting.	From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.
Length of hospital stay	measuring the length of hospital stay by days	From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Anesthetic related Complications	Any complication related to anesthesia, particularly respiratory complications, will be assessed clinically and instrumentally (chest ultrasonography for diaphragm motion)	postoperatively, From awakening up to 24 hours postoperatively, when the phrenic infiltration shows its effect before wearing off.

Collaborators and Investigators

• Sponsor: Papa Giovanni XXIII Hospital
• Investigators: Study Chair: Ezio Bonanomi, MD, papa Giovanni XXIII Hospital - Bergamo

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2024 Nov 7:rapm-2024-105960. doi: 10.1136/rapm-2024-105960. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cryoanalgesia pectus phrenic
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Bone Diseases, Developmental; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Funnel Chest
• Other Study ID Numbers: EPIC PHABULA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We are willingful to share, as researchers, any anonymized clinical data. However, italian law is quite strict about this possibility - anyway, if requested, we will do our best to communicate.

Drug and device information, study documents

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