Funnel ChestNCT05831137
Cryoanalgesia Aplication Time Optimization During Nuss Procedure
A study testing shorter cryoanalgesia in people with Funnel Chest and Excavatum, Pectus, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. 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?
- shorter cryoanalgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 31 Mar 2023to 10 Jul 2023
- 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
- informed concent signed for cryolesia
Who cannot join
- age 9 years or below
- refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University
Szczecin, 71-252
Sławomir Zacha, MD PhD, +48513100813, sekozacha@gmail.com
Jowita Biernawska, MDPhD, 501337073, lisienko@wp.pl
About this study
Official title: The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
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.
Read the 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.
- Conditions
- Funnel Chest, Excavatum, Pectus
- Being tested
- shorter cryoanalgesia
- Keywords
- nuss procedure, 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.
shorter cryoanalgesiaProcedure or surgery
duration time of cryoanalgesia
| Study group | Role | What they receive |
|---|---|---|
| intervention side | Experimental | duration of intercostal nerves cryolesia: 1 minute per left nerve Receives: Procedure: shorter cryoanalgesia |
| control side | No intervention | duration of intercostal nerves cryolesia: 2 minute per right nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
The worse pain occurrence during first 24 hours after operation.
numeric pain score, range from 0 to 10
Measured: up to 24 hours after operation
Secondary outcomes (3)
thoracic hypoaesthesia occurrence
cold test assessment (yes / no)
Measured: up to 24 hours after operation
residual wound or chest pain occurrence
the chest or wound chronic pain occurrence
Measured: postoperative months 1,3
duration of hospitalization
the lengh of the time in days spent in the hospital
Measured: estimated 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start31 Mar 2023
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Jul 2023 (estimated)
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
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jowita Biernawska, MD PhD, Study director, Pomeranian Medical Universitet Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831137
- Sponsor's protocol ID
- PUM NUSS
- Status last verified
- Mar 2023
- First submitted
- 4 Apr 2023
- Last updated
- 26 Apr 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
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.
PubMed 36283847
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimization of the Intercostal Nerves Cryoablation Aplication Time During Nuss Procedure
- ClinicalTrials.gov ID
- NCT05831137
- Acronym / sponsor ID
- PUM NUSS
- Conditions
- Funnel Chest, Excavatum, Pectus
- Keywords
- nuss procedure, cryoanalgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Jul 2023 (estimated)
- First posted
- 26 Apr 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention side | Experimental | Procedure: shorter cryoanalgesiaduration of intercostal nerves cryolesia: 1 minute per left nerve |
| control side | No intervention | –duration of intercostal nerves cryolesia: 2 minute per right nerve |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients undergoing pectus excavatum repair with modyfied minimal invasive thoracoscopic Nuss technique
- informed concent signed for cryolesia
Key exclusion criteria (2 listed)
- age 9 years or below
- refuse to receive cryoanalgesia or regional anaesthesia as a primary pain relief
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 |
|---|---|---|
| shorter cryoanalgesiaduration time of cryoanalgesia | Procedure or surgery | intervention side |
Primary outcome
The worse pain occurrence during first 24 hours after operation.
Time frame: up to 24 hours after operation
numeric pain score, range from 0 to 10
3 secondary outcomes
thoracic hypoaesthesia occurrence
Time frame: up to 24 hours after operation
residual wound or chest pain occurrence
Time frame: postoperative months 1,3
duration of hospitalization
Time frame: estimated 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Results publication: PubMed 36283847Zeineddin 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.
- Individual participant dataSharing planned: Yes. We invite others researchers to collaboration as multicenter study
Related trials for Funnel Chest
RecruitingObservational study
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Active, not recruiting
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Pain, Postoperative, Excavatum, Pectus
Recruiting
ES Catheter vs Cryoablation After Pectus Surgery
Pectus Excavatum
Active, not recruiting
Pectus Excavatum Camouflage (IT)
Pectus Excavatum
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 shorter 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jowita Biernawska, MD PhD (+48501337073, lisienko@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The worse pain occurrence 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 NCT05831137, 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 26 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.