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Completed

NCT Number: NCT05201820

Cryoanalgesia for Pain Management After Pectus Excavatum Repair

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.

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Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Giannina Gaslini

Genova, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoanalgesia

Device

Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side

Primary outcomes

  1. Quality of Life by PedsQL 23 items

    Time frame: Two weeks after surgery

    Quality of life after surgery

Secondary outcomes

  1. YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)

    Time frame: One week after surgery

    A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100

  2. Pain by VAS

    Time frame: 1-14 days after surgery

    Numeric pain score 0-10

  3. Thoracic hypo-aesthesia

    Time frame: Six months after surgery

    Cold test assessment (Yes/No)

Sponsors and collaborators

Lead sponsor

Istituto Giannina Gaslini

Other

Registry information

Official study title

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

Acronym: COPPER

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 21, 2022
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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