Pectus Excavatum Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• patients who undergo minimally invasive repair at the pediatric surgery department of our referral tertiary center

Locations
Other Locations
Italy
Sc Ricerca Clinica, Sviluppo E Innovazione
RECRUITING
Bergamo
Contact Information
Primary
Stefano Mariconti, MD
smariconti@asst-pg23.it
+39 035.267.5150 - 5149
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 50
Treatments
EPIC
patients treated with preoperative Earlier Percutaneous Intercostal Cryoneurolysis, from 2 to 7 days prior of surgery and postoperative systemic analgesia protocol.
PhICA
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.
Related Therapeutic Areas
Sponsors
Leads: Papa Giovanni XXIII Hospital

This content was sourced from clinicaltrials.gov