CryoanalgesiaNCT07923500
The Prevalence of Chronic Pain Following Cryoanalgesia and the Nuss Procedure.
An observational study of Cryoanalgesia and Pain Management, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The aim of the study is to analyze the prevalence of chronic pain, including neuropathic pain following operations for funnel chest deformity of the anterior chest wall in children. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cryoanalgesia, Pain Management, Chronic Pain
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 15 Oct 2025to 31 Dec 2027
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under 18 years of age diagnosed with funnel-shaped anterior chest wall deformity undergoing minimally invasive Nuss surgery.
Who may be able to join
- funnel chest deformity
- Haller index above 3,25
Who cannot join
- Thoracic deformity other than funnel chest;
- Advanced chronic respiratory or circulatory failure;
- Emergency surgery or reoperation;
- History of thoracotomy or thoracic surgery;
- Mental impairment precluding communication with the patient or lack of consent for cryoanalgesia or regional analgesia;
- History of allergy to local anaesthetic;
- History of taking medication for chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assesment Of The Prevalence Of Chronic Pain Following Intercostal Nerve Cryoanalgesia And The Nuss Procedure For Pectus Excavatum In Children.
The aim of the study is to analyze the prevalence of chronic pain, including neuropathic pain following operations for funnel chest deformity of the anterior chest wall in children.
Read the detailed description
Pectus excavatum is the most common congenital deformity of the anterior chest wall. The minimally invasive repair of pectus excavatum (MIRPE), is the standard surgical treatment. Intraoperative intercostal nerve cryoanalgesia (INC) has emerged as an important advance in postoperative pain management after MIRPE, reducing opioid consumption and length of hospital stay. Potential complications of intercostal nerve cryoanalgesia include transient sensory disturbances (hypoesthesia and paresthesia), neuropathic pain, local hematoma formation, infection, and injury to adjacent structures. Most sensory abnormalities are temporary and resolve spontaneously within several months.
We conducted a prospective observational before-and-after cohort study. The aim of the study was to analyze the prevalence of chronic pain, including neuropathic pain following operations for funnel chest deformity of the anterior chest wall in children with and without cryoanalgesia.
- Conditions
- Cryoanalgesia, Pain Management, Chronic Pain, Funnel Chest
- Medical subject headings
- Agnosia, Chronic Pain, Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| multimodal and cryoanalgesia (after group) | Not described | |
| multimodal without cryoanalgesia (before group) | Patients treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pain
The primary outcome was the incidence of chronic postsurgical pain at 3 months after surgery.
Measured: at 3 months after surgery
Secondary outcomes (1)
neuropathic pain
The incidence of neuropathic postsurgical pain at 3 months after surgery.
Measured: at 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Oct 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: We completed data collection in our university and we are waiting for the collaborating universities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryoanalgesiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923500
- Sponsor's protocol ID
- Stop chronic pain with cryo.
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment Of The Prevalence Of Chronic Pain Following Intercostal Nerve Cryoanalgesia And The Nuss Procedure For Pectus Excavatum In Children.
- ClinicalTrials.gov ID
- NCT07923500
- Acronym / sponsor ID
- Stop chronic pain with cryo.
- Conditions
- Cryoanalgesia, Pain Management, Chronic Pain, Funnel Chest
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: We completed data collection in our university and we are waiting for the collaborating universities.
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
The aim of the study is to analyze the prevalence of chronic pain, including neuropathic pain following operations for funnel chest deformity of the anterior chest wall in children.
Detailed description
Pectus excavatum is the most common congenital deformity of the anterior chest wall. The minimally invasive repair of pectus excavatum (MIRPE), is the standard surgical treatment. Intraoperative intercostal nerve cryoanalgesia (INC) has emerged as an important advance in postoperative pain management after MIRPE, reducing opioid consumption and length of hospital stay. Potential complications of intercostal nerve cryoanalgesia include transient sensory disturbances (hypoesthesia and paresthesia), neuropathic pain, local hematoma formation, infection, and injury to adjacent structures. Most sensory abnormalities are temporary and resolve spontaneously within several months.
We conducted a prospective observational before-and-after cohort study. The aim of the study was to analyze the prevalence of chronic pain, including neuropathic pain following operations for funnel chest deformity of the anterior chest wall in children with and without cryoanalgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multimodal and cryoanalgesia (after group) | – | – |
| multimodal without cryoanalgesia (before group) | – | –Patients treated |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years of age diagnosed with funnel-shaped anterior chest wall deformity undergoing minimally invasive Nuss surgery.
Key inclusion criteria (2 listed)
- funnel chest deformity
- Haller index above 3,25
Key exclusion criteria (7 listed)
- Thoracic deformity other than funnel chest;
- Advanced chronic respiratory or circulatory failure;
- Emergency surgery or reoperation;
- History of thoracotomy or thoracic surgery;
- Mental impairment precluding communication with the patient or lack of consent for cryoanalgesia or regional analgesia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
chronic pain
Time frame: at 3 months after surgery
The primary outcome was the incidence of chronic postsurgical pain at 3 months after surgery.
1 secondary outcome
neuropathic pain
Time frame: at 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided. NC
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryoanalgesia and Pain Management, 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 7 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: paused, as of the sponsor's last update on 6 Nov 2026. 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?
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?
chronic pain (time frame: at 3 months after surgery). 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 6 Nov 2026.