Cryoanalgesia for Pain Management After Pectus Excavatum Repair

Not Applicable

Completed

• Conditions: Pectus Excavatum
• Interventions: Device: Cryoanalgesia

• Registration Number: NCT05201820
• Lead Sponsor: Istituto Giannina Gaslini

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2022-01-09
• Study First Posted: 2022-01-21
• Study Start: 2022-02-01
• Status Verified: 2024-03
• Primary Completion: 2024-03-19
• Study Completion: 2024-03-19
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoanalgesia	Cryoanalgesia	Cryoanalgesia

Primary Outcome Measures

Name	Time	Method
Quality of Life by PedsQL 23 items	Two weeks after surgery	Quality of life after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istituto Giannina Gaslini; 🇮🇹 Genova, Italy