Funnel ChestNCT05570097
Cryoanalgesia to Prevent Acute and Chronic Pain Following Nuss Procedure
A study testing intercostal nerves cryoanalgesia in people with Funnel Chest and Excavatum, Pectus, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Funnel Chest, Excavatum, Pectus
- What is being tested?
- intercostal nerves cryoanalgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 28 Sep 2022to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
- aged 10 years or above 10
- informed consent signed for cryoanalgesia
Who cannot join
- Age of 9 years or below
- Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
- Any contraindication to cryoanalgesia
- Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryoanalgesia in Combination With the Novel Prehabilitation Program Back on Feet Are the Essential Parts of Enhanced Recovery Protocol in the Minimal Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation.
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).
Read the detailed description
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.
- Conditions
- Funnel Chest, Excavatum, Pectus
- Being tested
- intercostal nerves cryoanalgesia
- Keywords
- nuss procedure, ERAS, cryolesia, cryoanalgesia
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostal nerves cryoanalgesiaDevice
Intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy.
| Study group | Role | What they receive |
|---|---|---|
| "the before" group | No intervention | Control group as a standard therapy in Poland (regional analgesia: intrapleural or bilateral erector spine plane block added to multimodal analgesia). |
| "the after" group | Experimental | 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. Receives: Device: intercostal nerves cryoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The worse pain occurence during first 24 hours after operation
Numeric pain score. Range from 0 to 10.
Measured: up to 24 hours after operation
Secondary outcomes (8)
Analgesic consumption post operation
Total analgesic (including opioids) consumption for previous 24 hours
Measured: 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)
Measured: 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)
Measured: 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
Measured: Postoperative days 1, 2, 3, 4, 5 ,6
Residual wound or chest pain occurence
The chest or wound chronic pain occurrences
Measured: Postoperative months 1, 3
Total narcotic use post-operation
Total dose and number of days of opioids used during hospitalization
Measured: 0-6 postoperative days
Cost Analysis
total costs of hospitalization
Measured: estimated 1 week
Duration of hospitalization
the length of the time (in days) spent in the hospital
Measured: estimated 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start28 Sep 2022
- Primary completion10 Oct 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Funnel ChestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before - after study: First: control group as a standard treatment in Poland, review, then: interventional group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sławomir Zacha, Pomeranian Medical University Szczecin
- Investigators
- Jowita Biernawska, MD PhD, Study director, Pomeranian Medical Universitet Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570097
- Sponsor's protocol ID
- PomeranianMedicalUniveristy
- Status last verified
- Mar 2023
- First submitted
- 29 Sep 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We invite others researchers to collaboration as multicenter study.
Publications
Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.
PubMed 30935731
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoanalgesia in Combination With the Novel Prehabilitation Program Back on Feet Are the Essential Parts of Enhanced Recovery Protocol in the Minimal Invasive Modyfied Nuss Procedure of Children With Funnel Chest Deformation.
- ClinicalTrials.gov ID
- NCT05570097
- Acronym / sponsor ID
- PomeranianMedicalUniveristy
- Conditions
- Funnel Chest, Excavatum, Pectus
- Keywords
- nuss procedure, ERAS, cryolesia, cryoanalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before - after study: First: control group as a standard treatment in Poland, review, then: interventional group
| Arm | Type | Receives |
|---|---|---|
| "the before" group | No intervention | –Control group as a standard therapy in Poland (regional analgesia: intrapleural or bilateral erector spine plane block added to multimodal analgesia). |
| "the after" group | Experimental | Device: intercostal nerves cryoanalgesiaDuring modyfied Nuss thoracoscopy the intraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic NUSS technique
- aged 10 years or above 10
- informed consent signed for cryoanalgesia
Key exclusion criteria (4 listed)
- Age of 9 years or below
- Refuse to receive cryoanalgesia or regional analgesia as primary pain relief
- Any contraindication to cryoanalgesia
- Difficult follow-up for geographical reasons and/or impossibility by the patient to understand how to perform self-measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intercostal nerves cryoanalgesiaIntraoperative Cryolesia of at least 5 intercostal nerves added to regional analgesia: bilateral erector spine plane block and multimodal therapy. | Device | "the after" group |
Primary outcome
The worse pain occurence during first 24 hours after operation
Time frame: up to 24 hours after operation
Numeric pain score. Range from 0 to 10.
8 secondary outcomes
Analgesic consumption post operation
Time frame: Postoperative days 0, 1, 2, 3, 4, 5,6, as well as months 1 and 3
Thoracic hypo-aesthesia occurence
Time frame: up to 24 hours after operation
Assessment of sleeping quality
Time frame: Postoperative days 1, 2, 3, 4, 5 ,6
Postoperative nausea and vomiting (PONV) occurence
Time frame: Postoperative days 1, 2, 3, 4, 5 ,6
Residual wound or chest pain occurence
Time frame: Postoperative months 1, 3
Total narcotic use post-operation
Time frame: 0-6 postoperative days
Cost Analysis
Time frame: estimated 1 week
Duration of hospitalization
Time frame: estimated 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Results publication: PubMed 30935731Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.
- Individual participant dataSharing planned: Yes. We invite others researchers to collaboration as multicenter study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jowita Biernawska, MD PhD study director
Pomeranian Medical Universitet Szczecin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intercostal nerves cryoanalgesia in people with Funnel Chest and Excavatum, Pectus, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The worse pain occurence during first 24 hours after operation (time frame: up to 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.