Clinical trial NCT05831137: Cryoanalgesia Aplication Time Optimization During Nuss Procedure
Official title: The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Funnel Chest
Excavatum, Pectus
Keywords: nuss procedure
cryoanalgesia
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In each patient one side of the chest will be treated by standard metod and the second side will be treated with the novel method.
Primary purpose: TREATMENT

Brief summary: This study compared standard therapy (multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in subject undergoing minimal invasive modyfied Nuss procedure with thoracoscopy.

Detailed description: Funnel chest deformation may be a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain.

2 minutes per one intercostal nerve aplication cryoanalgesia as a part of multimodal analgesia is a standard protocol in many countries.

This Prospective Non-Randomized Study is a single institution pilot study designed to compare standard therapy (control side: multimodal analgesia with 2 minutes cryoanalgesia) versus a novel approach (multimodal analgesia with 1 minute cryoanalgesia) in each patient to address the need for better management of acute and long-term pain in the pediatric population diagnosed with funnel-chest and treated using the modyfied Nuss method.

All of the patients will receive a standard care according to Polish guidelines: multimodal analgesia with regional analgesia (bilateral erector spine plane block) with cryoanalgesia. The right intercostal nerves will be treated with 2 minutes cryoanalgesia (control side). The left side of the chest (left intercostal nerves) will be treated with 1 minute cryoanalgesia (intervention side).

The intraoperative cryoanalgesia will be performed using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited).

The study will assess the effectiveness of shorter aplication duration time of cryoanalgesia as a method of acute and long-term pain control and safety of the method.

Specific Aim: To determine if, compared with current 2 minutes cryoanalgesia protocol, 1 minute aplication time of cryoanalgesia is effective at the same level when consider pain control and postoperative functioning in each patient.

The results were compared in terms of demographics, right versus left side of the chest pain levels, quality and length of rehabilitation and patient satisfaction using the Quality of Life by modyfied Nuss questionnaire.

Eligibility criteria: Inclusion Criteria:

* patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
* informed concent signed for cryolesia

Exclusion Criteria:

* age 9 years or below
* refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief

Primary outcomes:
measure: The worse pain occurrence during first 24 hours after operation.
timeFrame: up to 24 hours after operation
Secondary outcomes:
measure: thoracic hypoaesthesia occurrence
timeFrame: up to 24 hours after operation
measure: residual wound or chest pain occurrence
timeFrame: postoperative months 1,3
measure: duration of hospitalization
timeFrame: estimated 4 days
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
Study officials:
affiliation: Pomeranian Medical Universitet Szczecin
name: Jowita Biernawska, MD PhD
role: STUDY_DIRECTOR
References:
citation: Zeineddin S, Goldstein SD, Linton S, DeBoer C, Alayleh A, Ortiz I, Sands L, Kujawa S, Suresh S, Ghomrawi H, Abdullah F. Effectiveness of one minute per level intercostal nerve cryoablation for postoperative analgesia after surgical correction of pectus excavatum. J Pediatr Surg. 2023 Jan;58(1):34-40. doi: 10.1016/j.jpedsurg.2022.09.032. Epub 2022 Sep 26.