An interventional study of Cryoanalgesia in Pectus Excavatum, sponsored by Istituto Giannina Gaslini. Completed at 1 site in Italy. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Istituto Giannina Gaslini · Not applicable, Interventional, and Treatment
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's enrollment of 88 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Epidural analgesia
Cryoanalgesia
Device: Cryoanalgesia
Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side
Quality of Life by PedsQL 23 items
Quality of life after surgery
Time frame: Two weeks after surgery
YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100
Time frame: One week after surgery
Pain by VAS
Numeric pain score 0-10
Time frame: 1-14 days after surgery
Thoracic hypo-aesthesia
Cold test assessment (Yes/No)
Time frame: Six months after surgery
Plan to share: Yes — Once final publication is accepted, other researchers can request IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: At the time of submission for publication
Access criteria: By request
Ran from Feb 2022 to primary completion in Mar 2024, 25 months.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's 25 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini