Cryoanalgesia vs. Epidural in the Nuss Procedure

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cryoanalgesia provides better pain control for minimally invasive pectus excavatum repair (the Nuss procedure) than thoracic epidural.

Detailed Description
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Pain control is a major challenge for physicians, who must ensure appropriate and effective pain control for their patients, while remaining mindful of the many negative effects of opioid dependence and addiction. Nowhere is there a more pressing need than in children and young adults, who are at high risk for drug abuse, and in post-operative care, since post-operative opioid use can be a starting point for long-term pain issues. Postoperative pain control in the Nuss procedure, minimally invasive repair of the congenital chest wall deformity known as pectus excavatum, remains a significant problem for the 3000 patients who undergo this procedure each year, mostly adolescents and young adults. Many multimodal analgesic regimens have been tried, but optimal treatment remains unknown. This study will test a novel and promising strategy of using intra-operative cryoanalgesia during the Nuss procedure. Cryoanalgesia is the localized, temporary freezing of peripheral nerves, which is performed at the time of the Nuss procedure. The study is a 20-subject prospective, randomized pilot trial comparing cryoanalgesia to thoracic epidural analgesia for post-operative pain control in patients undergoing the Nuss procedure. Subjects will be recruited from patients already scheduled for a Nuss procedure at our institution, and will undergo 1:1 randomization to either cryoanalgesia or thoracic epidural analgesia for perioperative pain control. During their hospitalization, patients' opiate usage will be prospectively recorded, and pain will be assessed twice per day. Upon discharge, patients will maintain a log of their opiate use, and will return to clinic at 2 weeks, 1 month, 3 months, and 1 year after Nuss procedure for post-operative assessment. Primary outcome is length of perioperative hospitalization, an objective measure that synthesizes many different aspects of a procedure and its subsequent post-operative course, including pain control. Secondary outcomes are post-operative narcotic usage and direct cost of perioperative hospitalization. Side effects of both interventions will also be assessed. This will be the first systematic investigation of cryoanalgesia for local nerve block in a thoracoscopic procedure, and the first study involving its use in adolescents and young adults. The results will have direct application for those undergoing the Nuss procedure to repair pectus excavatum. Investigators will also delineate a reproducible protocol for delivering cryoanalgesia thoracoscopically, to ensure others can safely and effectively use this method if it proves beneficial. Although the focus is on the small subset of patients who undergo the Nuss procedure, if a standardized approach to cryoanalgesia delivery in a thoracoscopic procedure has a positive effect on patient outcomes and cost of hospitalization, the technique could be applied to a variety of surgical procedures, as well as for other neuropathic pain.

Official Title
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Pain Control in the Nuss Procedure: A Prospective, Randomized Trial of Cryoanalgesia vs. Thoracic Epidural

Conditions
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Pectus Excavatum, Funnel Chest

Intervention / Treatment
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* Device: Cryoanalgesia
* Drug: Thoracic epidural (ropivicaine, fentanyl)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for Nuss procedure for pectus excavatum correction at least 13 years old at the time of the procedure Exclusion Criteria: age less than 13 years at time of procedure use of pain medication prior to procedure pectus carinatum, Poland's syndrome, or any chest wall anomaly other than pectus excavatum previous repair of pectus excavatum by any technique previous thoracic surgery congenital heart disease bleeding dyscrasia major anesthetic risk factors or history of previous problem with anesthesia pregnancy inability to communicate in English

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoanalgesia<br>Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure | Device: Cryoanalgesia<br> <br> * Other names: nerve freezing;|
| Active Comparator: Thoracic Epidural<br>Thoracic epidural (ropivicaine, fentanyl). | Drug: Thoracic epidural (ropivicaine, fentanyl)<br>* Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.<br>* Other names: Epidural;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospitalization | the length of the patient's in-hospital stay following admission for Nuss procedure | estimated one week or less | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Usage | Inpatient narcotic usage | Post Operative Hospital Stay | 
| Mean Neuropathic Pain Score at One Year | Neuropathic specific pain (described as burning, electrical or tingling sensations) was assessed by study questionnaire via numerical pain scale (1 to 10, with 10 representing a maximum score, or worst pain possible). | one year | 
| Cost Analysis | cost analysis of initial hospitalization following Nuss procedure | estimated one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nuss, Nuss Procedure, pectus excavatum, cryoanalgesia