Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Pr… (NCT07290582) | Clinical Trial Compass
RecruitingNot Applicable
Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure
Italy50 participantsStarted 2023-09-14
Plain-language 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
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether adding a phrenic nerve infiltration to cryoanalgesia helps with pain after the Nuss procedure — how might affecting the phrenic nerve impact breathing or diaphragm function in the weeks after surgery, and is that a risk worth discussing for my specific situation?
2Since this trial is listed as 'Phase NA,' what does that mean for how much is already known about the safety and effectiveness of this particular combination of techniques, and should that influence my decision?
3How does the pain control approach being studied in this trial compare to what would be offered as standard pain management after a Nuss procedure, and is there a reason to consider one over the other for my case?
4The trial mentions phrenic nerve-related diaphragmatic impairment as one of the conditions being studied — how would the care team monitor for that complication, and what would happen if I experienced it during the recovery period?
5Given that this is a surgical trial for pectus excavatum correction, what are the logistics of participation — would I need to have the Nuss procedure done at a specific center, and how would my follow-up pain assessments be handled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain
Timeframe: From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.