Cryoanalgesia for Pain Management After Pectus Excavatum Repair

Study Overview
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Brief Summary
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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.

Official Title
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Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial

Conditions
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Pectus Excavatum

Intervention / Treatment
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* Device: Cryoanalgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing pectus excavatum repair with NUSS technique aged 12 years or above12 informed consent signed for cryoanalgesia Exclusion Criteria: - 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br>Epidural analgesia | |
| Experimental: Cryoanalgesia<br>Cryoanalgesia | Device: Cryoanalgesia<br>* Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life by PedsQL 23 items | Quality of life after surgery | Two weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| YAPFAQ (Youth Acute Pain Functional Ability Questionnaire) | A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100 | One week after surgery | 
| Pain by VAS | Numeric pain score 0-10 | 1-14 days after surgery | 
| Thoracic hypo-aesthesia | Cold test assessment (Yes/No) | Six months after surgery |