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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07290582
Acronym
PHABULA
Enrollment
50
Registered
2025-12-18
Start date
2023-09-14
Completion date
2026-09-15
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cryoanalgesia pectus phrenic

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

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)

Interventions

None listed

Sponsors

Papa Giovanni XXIII Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painFrom 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

MeasureTime frameDescription
Time to mobilization after surgeryFrom 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.
Length of hospital stayFrom surgery (Day 0) through hospital discharge, up to 7 days postoperatively.measuring the length of hospital stay by days

Countries

Italy

Contacts

STUDY_CHAIREzio Bonanomi, MD

papa Giovanni XXIII Hospital - Bergamo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026