Pectus ExcavatumCryo-OneNCT06935799
Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
A study testing One minute intercostal nerves cryoanalgesia and Two minutes intercostal nerves cryoanalgesia in people with Pectus Excavatum and Funnel Chest, run by Children's Memorial Health Institute, Poland at 1 site in Poland.
Trial summary
Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pectus Excavatum, Funnel Chest
- What is being tested?
- One minute intercostal nerves cryoanalgesia and Two minutes intercostal nerves cryoanalgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 25 Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pectus excavatum repair with MIRPE
- Written consent for corrective surgery with intraoperative cryoanalgesia
- Written consent to participate in the study
- Age >12 and < 18 years
Who cannot join
- History of previous thoracic surgeries
- Reoperation for chest deformity
- Contraindication for cryoanalgesia
- Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
The Children's Memorial Health Institute
Warsaw, Wybierz Województwo, 02-829
Mateusz Ciopiński, MD, PhD, 0048228151360, m.ciopinski@ipczd.pl
About this study
Official title: Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.
This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.
- Conditions
- Pectus Excavatum, Funnel Chest
- Being tested
- One minute intercostal nerves cryoanalgesia, Two minutes intercostal nerves cryoanalgesia
- Keywords
- cryoanalgesia, pain management, pectus excavatum, funnel chest
- Medical subject headings
- Funnel Chest, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One minute intercostal nerves cryoanalgesiaProcedure or surgery
One-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
Two minutes intercostal nerves cryoanalgesiaProcedure or surgery
Two-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7
| Study group | Role | What they receive |
|---|---|---|
| One minute cryoanalgesia | Experimental | Not described Receives: Procedure: One minute intercostal nerves cryoanalgesia |
| Two minutes cryoanalgesia | Active comparator | Not described Receives: Procedure: Two minutes intercostal nerves cryoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain level according to Numerical Rating Scale (NRS)
Measured: 1 week
Secondary outcomes (4)
Opioid consumption
Measured: 1 week
Duration of the surgery
Measured: 1 day
Length of postoperative hospital stay
Measured: 1 week
Occurence of early complications
Measured: 30 days from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start25 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pectus ExcavatumStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Ciopiński, Children's Memorial Health Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935799
- Sponsor's protocol ID
- 37/KBE/2024
- Acronym
- Cryo-One
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06935799
- Acronym / sponsor ID
- Cryo-One / 37/KBE/2024
- Conditions
- Pectus Excavatum, Funnel Chest
- Keywords
- cryoanalgesia, pain management, pectus excavatum, funnel chest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.
This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One minute cryoanalgesia | Experimental | Procedure: One minute intercostal nerves cryoanalgesia |
| Two minutes cryoanalgesia | Active comparator | Procedure: Two minutes intercostal nerves cryoanalgesia |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pectus excavatum repair with MIRPE
- Written consent for corrective surgery with intraoperative cryoanalgesia
- Written consent to participate in the study
- Age >12 and < 18 years
Key exclusion criteria (4 listed)
- History of previous thoracic surgeries
- Reoperation for chest deformity
- Contraindication for cryoanalgesia
- Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety
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 |
|---|---|---|
| One minute intercostal nerves cryoanalgesiaOne-minute cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7 | Procedure or surgery | One minute cryoanalgesia |
| Two minutes intercostal nerves cryoanalgesiaTwo-minutes cryoanalgesia will be applied bilaterally to each of the intercostal nerves from Th3 to Th7 | Procedure or surgery | Two minutes cryoanalgesia |
Primary outcome
Postoperative pain level according to Numerical Rating Scale (NRS)
Time frame: 1 week
4 secondary outcomes
Opioid consumption
Time frame: 1 week
Duration of the surgery
Time frame: 1 day
Length of postoperative hospital stay
Time frame: 1 week
Occurence of early complications
Time frame: 30 days from the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One minute intercostal nerves cryoanalgesia and Two minutes intercostal nerves cryoanalgesia in people with Pectus Excavatum and Funnel Chest, run by Children's Memorial Health Institute, Poland 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 4 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: looking for participants now, as of the sponsor's last update on 1 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain level according to Numerical Rating Scale (NRS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2025.