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NCT07290582
Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure
Conditions: Pectus Excavatum, Cryo Analgesia, Phrenic Nerve-related Diaphragmatic Impairment
Sex: All
Ages: 14 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Papa Giovanni XXIII Hospital
Location: Sc Ricerca Clinica, Sviluppo E Innovazione Bergamo BG
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07290582). StuddyBuddy aggregates publicly available trial information.