Pectus Excavatum
Conditions
Brief 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 (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.
Interventions
DEVICECryoanalgesia
Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side
Sponsors
Istituto Giannina Gaslini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life by PedsQL 23 items | Two weeks after surgery | Quality of life after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| YAPFAQ (Youth Acute Pain Functional Ability Questionnaire) | One week after surgery | A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100 |
| Pain by VAS | 1-14 days after surgery | Numeric pain score 0-10 |
| Thoracic hypo-aesthesia | Six months after surgery | Cold test assessment (Yes/No) |
Countries
Italy
Outcome results
None listed