COPPER: Cryoanalgesia for Pain Management After Pectus Excavatum Repair

• Sponsor: Istituto Giannina Gaslini (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05201820
• Collaborator: (none)
• Enrollment: 88
• Arms: 2
• Anticipated Duration (Months): 10.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pectus Excavatum	Device: Cryoanalgesia	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pediatric Quality of Life scale (23 items) [Two weeks after surgery]

   Quality of life (0-100)

Secondary Outcome Measures

1. 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

2. Postoperative pain [Up to 14 days after surgery]

   Numeric pain score. Range from 0 to 10.

3. Thoracic hypo-aesthesia [Six months after surgery]

   Cold test assessment (Yes/No)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Istituto Giannina Gaslini

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Nicola Disma, MD, Head of Research and Innovation Unit, Istituto Giannina Gaslini
• ClinicalTrials.gov Identifier: NCT05201820
• Other Study ID Numbers: COPPER
• First Posted: Jan 21, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Funnel Chest

Study Results

No Results Posted as of Jan 21, 2022