Cryoanalgesia for Pain Management After Pectus Excavatum Repair

NCT05201820 | Completed DMC

• 1 other identifier: COPPER
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• Quality of Life by PedsQL 23 items

  Quality of life after surgery

  Two weeks after surgery

Secondary Outcomes (3)

• YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)

  One week after surgery

• Pain by VAS

  1-14 days after surgery

• Thoracic hypo-aesthesia

  Six months after surgery

Study Arms (2)

Standard of care

NO INTERVENTION

Epidural analgesia

Cryoanalgesia

EXPERIMENTAL

Cryoanalgesia

Device: Cryoanalgesia

Interventions

Cryoanalgesia DEVICE

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

Cryoanalgesia

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing pectus excavatum repair with NUSS technique
• aged 12 years or above12
• informed consent signed for cryoanalgesia

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Istituto Giannina Gaslini: lead

Study Sites (1)

Istituto Giannina Gaslini

Genova, Italy

Location

Related Publications (2)

• Arshad SA, Hatton GE, Ferguson DM, Li LT, Austin MT, Tsao K; PAPS SPONSOR. Cryoanalgesia enhances recovery from minimally invasive repair of pectus excavatum resulting in reduced length of stay: A case-matched analysis of NSQIP-Pediatric patients. J Pediatr Surg. 2021 Jul;56(7):1099-1102. doi: 10.1016/j.jpedsurg.2021.03.017. Epub 2021 Mar 24.

  PMID: 33853733 BACKGROUND

• Bastianello M, Torre M, Bonfiglio R, Calevo MG, Palomba L, Uva P, Kanapari A, Lorenzoni G, Disma N; COPPER consortium. Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial. Paediatr Anaesth. 2025 May;35(5):347-358. doi: 10.1111/pan.15090. Epub 2025 Mar 4.

  PMID: 40035332 DERIVED

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Innovation Unit

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: January 21, 2022
• Study Start: February 1, 2022
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At the time of submission for publication
• Access Criteria: By request

Locations

IT (1)