Clinical Trial

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

Study acronym: PHABULA
Recruiting
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Record status
This record was last updated June 16, 2026 (before its estimated July 16, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-16.
Status change: Completed → Recruiting 2026-06-13
Trial Details
NCT Number NCT07290582
Lead Sponsor Papa Giovanni XXIII Hospital
Conditions Pectus Excavatum, Cryo Analgesia, Phrenic Nerve-related Diaphragmatic Impairment
Enrollment 50 participants
Start Date 2023-09-14
Primary Completion 2026-07-16 (estimated)
Study Completion 2026-08-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-16