Cryoanalgesia for Pain Management After Pectus Excavatum Repair

Pectus Excavatum Clinical Trial

— COPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201820
• Other study ID #: COPPER
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 19, 2024

Study information

• Verified date: March 2024
• Source: Istituto Giannina Gaslini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 19, 2024
• Est. primary completion date: March 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Giannina Gaslini	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Giannina Gaslini

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life by PedsQL 23 items	Quality of life after surgery	Two weeks after surgery
Secondary	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
Secondary	Pain by VAS	Numeric pain score 0-10	1-14 days after surgery
Secondary	Thoracic hypo-aesthesia	Cold test assessment (Yes/No)	Six months after surgery