An interventional study of intercostal nerves cryoanalgesia in Funnel Chest and Excavatum, Pectus, sponsored by Pomeranian Medical University Szczecin. Completed at 1 site in Poland. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Pomeranian Medical University Szczecin · Not applicable, Interventional, and Treatment
This Study study compared standard therapy (multimodal and regional analgesia) versus a novel approach (Cryoanalgesia combined with bilateral erector spine plane block and multimodal analgesia) in subjects undergoing minimal invasive modyfied Nuss procedure (thoracoscopy).
Funnel chest deformation is a great challenge for therapeutic teams due to severe pain in the postoperative period as well as chronic pain. The use of many analgesic drugs, including opioids, is associated with adverse side effects, difficulties with rehabilitation, an increased risk of complications, prolonged hospitalisation, and the cost of the procedure. Cryoanalgesia as a part of multimodal analgesia along with the education and prehabilitation of the patient according to the novel original educational - training application 'Back on Feet' as well as the interdisciplinary care in accordance with the enhanced recovery after surgery (ERAS) protocol, which has a real impact on the optimisation of perioperative care.
This Before - After Study is a single institution pilot study designed to compare standard therapy (control group: regional analgesia: intrapleural or bilateral erector spine plane block) versus a novel approach (interventional group: Cryoanalgesia combined with bilateral single shot erector spine plane block) 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.
First group received a standard care according to Polish guidelines. The data of control group analysed and the interdisciplinary team work protocol will be introduced to the interventional group. The interventional group was prepared according to prehabilitation with the 'Back on feet' application and perioperative ERAS protocols. The patients of interventional group received intraoperative cryoanalgesia using the Cryo-S Painless device (Metrum - Cryoflex Polska Limited) as an additional procedure to multimodal analgesia. This is the first time that the cryoanalgesia procedure was performed in children in Poland.
The aims of the study were the assessment the effectiveness of cryoanalgesia as a method of acute and long-term pain control, safety of the method and the impact of preoperative preparation according to the 'Back on Feet' program introduced as a part of ERAS protocol.
Specific Aim 1: To determine if, compared with current analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain.
Hypothesis 1a (primary): The severity of surgically-related pain was significantly decreased from postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Hypothesis 1b: The incidence and severity of chronic pain was significantly decreased 3 months following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
Specific Aim 2: To determine if, compared with current analgesia, the addition of cryoanalgesia improves postoperative functioning.
Hypothesis 2a: Following modyfied Nuss procedure the range of motion and independence was significantly increased in the 2 postoperative day following operation with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.
The results were compared in terms of demographics, pain levels, side effects of the pain relief medications in the postoperative period, quality and length of rehabilitation, patient satisfaction using the Quality of Life by modyfied Nuss questionnaire, and the total costs of hospitalization.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 40 is close to 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group as a standard therapy in Poland (regional analgesia: intrapleural or bilateral erector spine plane block added to multimodal analgesia).
During modyfied Nuss thoracoscopy the intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.
Device: intercostal nerves cryoanalgesia
Intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.
The worse pain occurence during first 24 hours after operation
Numeric pain score. Range from 0 to 10.
Time frame: up to 24 hours after operation
Analgesic consumption post operation
Total analgesic (including opioids) consumption for previous 24 hours
Time frame: Postoperative days 0, 1, 2, 3, 4, 5,6, as well as months 1 and 3
Thoracic hypo-aesthesia occurence
Cold test assessment (Yes/No)
Time frame: up to 24 hours after operation
Assessment of sleeping quality
Collect difficulties of sleeping due to pain? (binary answer: yes or no; not based on a scale or instrument)
Time frame: Postoperative days 1, 2, 3, 4, 5 ,6
Postoperative nausea and vomiting (PONV) occurence
binary answer: yes or no; not based on a scale or instrument
Time frame: Postoperative days 1, 2, 3, 4, 5 ,6
Residual wound or chest pain occurence
The chest or wound chronic pain occurrences
Time frame: Postoperative months 1, 3
Total narcotic use post-operation
Total dose and number of days of opioids used during hospitalization
Time frame: 0-6 postoperative days
Cost Analysis
total costs of hospitalization
Time frame: estimated 1 week
Duration of hospitalization
the length of the time (in days) spent in the hospital
Time frame: estimated 1 week
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 contact to Principal Investigator
This study is completed, 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