Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorPapa Giovanni XXIII Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
patients who undergo minimally invasive repair at the pediatric surgery department of our referral tertiary center
Disqualifiers
patients who refuse OR whose parents refuse to participate in the study
Trial population
Adolescents and young adults with pectus excavatum undergoing the Nuss procedure for its correction
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: EPIC
Group B: PhICA
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.Other outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov