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

NCT07290582 — Completed, 50 participants, Papa Giovanni XXIII Hospital
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RegistryNCT07290582, acronym PHABULA
StatusCompleted
Study typeObservational
Enrollment50 (Actual)
SponsorPapa Giovanni XXIII Hospital (Other)
ConditionsPectus Excavatum, Cryo Analgesia, Phrenic Nerve-related Diaphragmatic Impairment
Datesstart 2023-09-14, primary completion 2026-09-15, completion 2026-09-15, first posted 2025-12-18, last updated 2026-09-15
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Pectus Excavatum All trials for Cryo Analgesia

-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

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+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)

+Arms and interventions

ArmTypeInterventionsDescription
EPICpatients treated with preoperative Earlier Percutaneous Intercostal Cryoneurolysis, from 2 to 7 days prior of surgery and postoperative systemic analgesia protocol.
PhICApatients 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.

+Outcome measures

Primary outcomes

  • Postoperative pain [From 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 outcomes

  • Time to mobilization after surgery [From 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 stay [From surgery (Day 0) through hospital discharge, up to 7 days postoperatively.]: measuring the length of hospital stay by days

Other outcomes

  • Early Anesthetic related Complications [postoperatively, From awakening up to 24 hours postoperatively, when the phrenic infiltration shows its effect before wearing off.]: Any complication related to anesthesia, particularly respiratory complications, will be assessed clinically and instrumentally (chest ultrasonography for diaphragm motion)

+Eligibility

Sex: All, ages: 14 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Sc Ricerca Clinica, Sviluppo E InnovazioneBergamo, BGItaly

+Publications

  • Hung YA, Sun CK, Chiang MH, Chen JY, Ko CC, Chen CC, Chen Y, Teng IC, Hung KC. Effect of Intraoperative Phrenic Nerve Infiltration on Postoperative Ipsilateral Shoulder Pain After Thoracic Surgeries: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3334-3343. doi: 10.1053/j.jvca.2022.04.016. Epub 2022 Apr 15. PMID 35570082
  • Blichfeldt-Eckhardt MR, Laursen CB, Berg H, Holm JH, Hansen LN, Ording H, Andersen C, Licht PB, Toft P. A randomised, controlled, double-blind trial of ultrasound-guided phrenic nerve block to prevent shoulder pain after thoracic surgery. Anaesthesia. 2016 Dec;71(12):1441-1448. doi: 10.1111/anae.13621. Epub 2016 Sep 16. PMID 27634451
  • Results publication: Mariconti S, Bronco A, Pellicioli I, Chiudinelli L, Cattaneo M, Cheli M, Bonanomi E. Earlier preoperative percutaneous intercostal cryoanalgesia improves recovery after pectus excavatum surgery. Reg Anesth Pain Med. 2026 Feb 5;51(2):200-207. doi: 10.1136/rapm-2024-105960. PMID 39510802

+Investigators