An observational study in Pectus Excavatum, Cryo Analgesia and Phrenic Nerve-related Diaphragmatic Impairment, sponsored by Papa Giovanni XXIII Hospital. Completed at 1 site in Italy. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Papa Giovanni XXIII Hospital · Observational
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
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)
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 50 is below the median of 68 across 32 observational studies indexed under Funnel Chest.
Browse Funnel Chest studies →Papa Giovanni XXIII Hospital is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
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Adolescents and young adults with pectus excavatum undergoing the Nuss procedure for its correction
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients treated with preoperative Earlier Percutaneous Intercostal Cryoneurolysis, from 2 to 7 days prior of surgery and postoperative systemic analgesia protocol.
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.
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.
Time frame: From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.
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.
Time frame: From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.
Length of hospital stay
measuring the length of hospital stay by days
Time frame: From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.
Early Anesthetic related Complications
Any complication related to anesthesia, particularly respiratory complications, will be assessed clinically and instrumentally (chest ultrasonography for diaphragm motion)
Time frame: postoperatively, From awakening up to 24 hours postoperatively, when the phrenic infiltration shows its effect before wearing off.
Plan to share: Undecided — 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.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Papa Giovanni XXIII Hospital