Pectus ExcavatumCOPPERNCT05201820
Cryoanalgesia for Pain Management After Pectus Excavatum Repair
A study testing Cryoanalgesia in people with Pectus Excavatum, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial. Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pectus Excavatum
- What is being tested?
- Cryoanalgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 19 Mar 2024
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing pectus excavatum repair with NUSS technique
- aged 12 years or above12
- informed consent signed for cryoanalgesia
Who cannot join
- Age of 11 years or below
- Refuse to receive cryoanalgesia or epidural catheter 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 for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial.
Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery.
Read more
Randomized active controlled, parallel group, single-centre, trial (category IIb medical device).
88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia).
PedsQLscale (23 items) two weeks after surgery.
Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.
- Conditions
- Pectus Excavatum
- Being tested
- 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.
CryoanalgesiaDevice
Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Epidural analgesia |
| Cryoanalgesia | Experimental | Cryoanalgesia Receives: Device: Cryoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life by PedsQL 23 items
Quality of life after surgery
Measured: Two weeks after surgery
Secondary outcomes (3)
YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100
Measured: One week after surgery
Pain by VAS
Numeric pain score 0-10
Measured: 1-14 days after surgery
Thoracic hypo-aesthesia
Cold test assessment (Yes/No)
Measured: Six 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 posted21 Jan 2022
- Study start1 Feb 2022
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Disma, MD, Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201820
- Sponsor's protocol ID
- COPPER
- Acronym
- COPPER
- Status last verified
- Mar 2024
- First submitted
- 20 Sep 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once final publication is accepted, other researchers can request IPD
Publications
Arshad SA, Hatton GE, Ferguson DM, Li LT, Austin MT, Tsao K; PAPS SPONSOR. Cryoanalgesia enhances recovery from minimally invasive repair of pectus excavatum resulting in reduced length of stay: A case-matched analysis of NSQIP-Pediatric patients. J Pediatr Surg. 2021 Jul;56(7):1099-1102. doi: 10.1016/j.jpedsurg.2021.03.017. Epub 2021 Mar 24.
PubMed 33853733Bastianello M, Torre M, Bonfiglio R, Calevo MG, Palomba L, Uva P, Kanapari A, Lorenzoni G, Disma N; COPPER consortium. Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial. Paediatr Anaesth. 2025 May;35(5):347-358. doi: 10.1111/pan.15090. Epub 2025 Mar 4.
PubMed 40035332
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05201820
- Acronym / sponsor ID
- COPPER / COPPER
- Conditions
- Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 21 Jan 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.
Cryoanalgesia for pain management after pectus excavatum repair. COPPER study (CryoanalgesiafOr Pain management after Pectus Excavatum Repair): a randomized controlled trial.
Determine if, in patients more than 12 years of age having cryoanalgesia for pectus excavatum repair analgesia improves the standard of care (epidural analgesia) in term of pain relief and return to normal life 2 weeks after surgery.
Randomized active controlled, parallel group, single-centre, trial (category IIb medical device).
88 patients aged more than 12 years of age scheduled for pectus excavatum repair. After randomization, patients will receive intraoperative cryo-analgesia or standard of care (epidural-analgesia).
PedsQLscale (23 items) two weeks after surgery.
Patients will be followed for 6 months after surgery to determine time until return to normal life and occurrence of any complication related to the use of cryo-analgesia. Numeric Rating Scale (NRS), CALI9, YAPFAQ will be measured at fixed times to determine pain intensity and limitations due to pain. Risk factors for prolonged pain and time needed until achieving discharge criteria from hospital will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Epidural analgesia |
| Cryoanalgesia | Experimental | Device: CryoanalgesiaCryoanalgesia |
Who may qualify
- Ages
- 12 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 NUSS technique
- aged 12 years or above12
- informed consent signed for cryoanalgesia
Key exclusion criteria (4 listed)
- Age of 11 years or below
- Refuse to receive cryoanalgesia or epidural catheter 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 |
|---|---|---|
| CryoanalgesiaCryoanalgesia will be applied during surgery on 6 intercostal nerves each side | Device | Cryoanalgesia |
Primary outcome
Quality of Life by PedsQL 23 items
Time frame: Two weeks after surgery
Quality of life after surgery
3 secondary outcomes
YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
Time frame: One week after surgery
Pain by VAS
Time frame: 1-14 days after surgery
Thoracic hypo-aesthesia
Time frame: Six months after surgery
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 20 Mar 2024.
- Background: PubMed 33853733Arshad SA, Hatton GE, Ferguson DM, Li LT, Austin MT, Tsao K; PAPS SPONSOR. Cryoanalgesia enhances recovery from minimally invasive repair of pectus excavatum resulting in reduced length of stay: A case-matched analysis of NSQIP-Pediatric patients. J Pediatr Surg. 2021 Jul;56(7):1099-1102. doi: 10.1016/j.jpedsurg.2021.03.017. Epub 2021 Mar 24.
- Derived from this study: PubMed 40035332Bastianello M, Torre M, Bonfiglio R, Calevo MG, Palomba L, Uva P, Kanapari A, Lorenzoni G, Disma N; COPPER consortium. Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial. Paediatr Anaesth. 2025 May;35(5):347-358. doi: 10.1111/pan.15090. Epub 2025 Mar 4.
- Individual participant dataSharing planned: Yes. Once final publication is accepted, other researchers can request IPD
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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?
A study testing Cryoanalgesia in people with Pectus Excavatum, run by Istituto Giannina Gaslini at 1 site in Italy.
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 20 Mar 2024. 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 Italy. 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?
Quality of Life by PedsQL 23 items (time frame: Two weeks after surgery). 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 NCT05201820, which also lists 2 linked publications.
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 20 Mar 2024.