Cryoanalgesia for Pain Management After Pectus Excavatum Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Pectus Excavatum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of care

Epidural analgesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Cryoanalgesia

Group Type EXPERIMENTAL

Cryoanalgesia

Intervention Type DEVICE

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

Interventions

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Cryoanalgesia

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No