Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER)

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

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.

Study Overview

• Status: Completed
• Conditions: Pectus Excavatum
• Intervention / Treatment: Device: Cryoanalgesia

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicola Disma; Phone Number: +3901056362445; Email: nicoladisma@gmail.com
• Study Contact Backup: Name: Marco Garrone; Phone Number: +3901056361; Email: marcogarrone@gaslini.org

Study Locations

• Italy
  • Genova, Italy
    • Istituto Giannina Gaslini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Epidural analgesia
Experimental: Cryoanalgesia	Device: Cryoanalgesia; Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side

What is the study measuring?

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
Thoracic hypo-aesthesia	Cold test assessment (Yes/No)	Six months after surgery
Pain by VAS	Numeric pain score 0-10	1-14 days after surgery

Collaborators and Investigators

• Sponsor: Istituto Giannina Gaslini

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: January 9, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: COPPER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once final publication is accepted, other researchers can request IPD
• IPD Sharing Time Frame: At the time of submission for publication
• IPD Sharing Access Criteria: By request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No