An interventional study of shorter cryoanalgesia in Funnel Chest and Excavatum, Pectus, sponsored by Pomeranian Medical University Szczecin. Status unknown at 1 site in Poland. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Pomeranian Medical University Szczecin · Not applicable, Interventional, and Treatment
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.
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Pomeranian Medical University Szczecin is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
duration of intercostal nerves cryolesia: 1 minute per left nerve
Procedure: shorter cryoanalgesia
duration of intercostal nerves cryolesia: 2 minute per right nerve
duration time of cryoanalgesia
The worse pain occurrence during first 24 hours after operation.
numeric pain score, range from 0 to 10
Time frame: up to 24 hours after operation
thoracic hypoaesthesia occurrence
cold test assessment (yes / no)
Time frame: up to 24 hours after operation
residual wound or chest pain occurrence
the chest or wound chronic pain occurrence
Time frame: postoperative months 1,3
duration of hospitalization
the lengh of the time in days spent in the hospital
Time frame: estimated 4 days
Plan to share: Yes — We invite others researchers to collaboration as multicenter study
Supporting information: Study protocol
Time frame: up to 12 months from the beginning of the study
Access criteria: by contacy to the Principal Investigator
Started Mar 2023 (actual). Primary completion is estimated for Jun 2023, 2 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Pomeranian Medical University Szczecin