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NCT Number: NCT07290582

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

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

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cryo Analgesia Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Phrenic Nerve-related Diaphragmatic Impairment

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sc Ricerca Clinica, Sviluppo E Innovazione

Bergamo, BG, 24100, Italy

Location status: Recruiting

Location contact

Monia Lorini, director

CONTACT

[email protected]

+39-035-2673341/4432

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative pain

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

    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.

Secondary outcomes

  1. Time to mobilization after surgery

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

    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.

  2. Length of hospital stay

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

    measuring the length of hospital stay by days

Other outcomes

  1. Early Anesthetic related Complications

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

    Any complication related to anesthesia, particularly respiratory complications, will be assessed clinically and instrumentally (chest ultrasonography for diaphragm motion)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Mariconti, MD

CONTACT

[email protected]

+39 035.267.5150 - 5149

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Acronym: PHABULA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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