Excavatum, Pectus, Funnel Chest
Conditions
Keywords
nuss procedure, cryoanalgesia
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.
Interventions
PROCEDUREshorter cryoanalgesia
duration time of cryoanalgesia
Sponsors
Pomeranian Medical University Szczecin
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The worse pain occurrence during first 24 hours after operation. | up to 24 hours after operation | numeric pain score, range from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| thoracic hypoaesthesia occurrence | up to 24 hours after operation | cold test assessment (yes / no) |
| residual wound or chest pain occurrence | postoperative months 1,3 | the chest or wound chronic pain occurrence |
| duration of hospitalization | estimated 4 days | the lengh of the time in days spent in the hospital |
Countries
Poland
Contacts
Primary ContactJowita Biernawska, MD PhD
Backup ContactSlawomir Zacha, MD PhD
Outcome results
None listed