Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER)

Istituto Giannina Gaslini

Status

Completed

Conditions

Pectus Excavatum

Treatments

Device: Cryoanalgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05201820

COPPER

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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