Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER)
Primary Purpose
Pectus Excavatum
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cryoanalgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pectus Excavatum
Eligibility Criteria
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
Sites / Locations
- Istituto Giannina GasliniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Cryoanalgesia
Arm Description
Epidural analgesia
Cryoanalgesia
Outcomes
Primary Outcome Measures
Quality of Life by PedsQL 23 items
Quality of life after surgery
Secondary Outcome Measures
YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100
Pain by VAS
Numeric pain score 0-10
Thoracic hypo-aesthesia
Cold test assessment (Yes/No)
Full Information
NCT ID
NCT05201820
First Posted
September 20, 2021
Last Updated
April 24, 2023
Sponsor
Istituto Giannina Gaslini
1. Study Identification
Unique Protocol Identification Number
NCT05201820
Brief Title
Cryoanalgesia for Pain Management After Pectus Excavatum Repair
Acronym
COPPER
Official Title
Cryoanalgesia for Pain Management After Pectus Excavatum Repair. COPPER Study (CryoanalgesiafOr Pain Management After Pectus Excavatum Repair): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Giannina Gaslini
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Epidural analgesia
Arm Title
Cryoanalgesia
Arm Type
Experimental
Arm Description
Cryoanalgesia
Intervention Type
Device
Intervention Name(s)
Cryoanalgesia
Intervention Description
Cryoanalgesia will be applied during surgery on 6 intercostal nerves each side
Primary Outcome Measure Information:
Title
Quality of Life by PedsQL 23 items
Description
Quality of life after surgery
Time Frame
Two weeks after surgery
Secondary Outcome Measure Information:
Title
YAPFAQ (Youth Acute Pain Functional Ability Questionnaire)
Description
A scale for assessment of activity limitations in children and adolescents. Range fro 0 to 100
Time Frame
One week after surgery
Title
Pain by VAS
Description
Numeric pain score 0-10
Time Frame
1-14 days after surgery
Title
Thoracic hypo-aesthesia
Description
Cold test assessment (Yes/No)
Time Frame
Six months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Disma
Phone
+3901056362445
Email
nicoladisma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Garrone
Phone
+3901056361
Email
marcogarrone@gaslini.org
Facility Information:
Facility Name
Istituto Giannina Gaslini
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Iengo
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33853733
Citation
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.
Results Reference
background
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Cryoanalgesia for Pain Management After Pectus Excavatum Repair
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