Cryoanalgesia vs. Epidural in the Nuss Procedure

Phase 4

Completed

Conditions: Pectus Excavatum
Funnel Chest

Interventions: Device: Cryoanalgesia
Drug: Thoracic epidural (ropivicaine, fentanyl)

Registration Number: NCT02721017

Lead Sponsor: University of California, San Francisco

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoanalgesia	Cryoanalgesia	Cryoanalgesia performed thoracoscopically under general anesthesia by the patient's surgeon at the time of the Nuss procedure
Thoracic Epidural	Thoracic epidural (ropivicaine, fentanyl)	Thoracic epidural (ropivicaine, fentanyl).

Primary Outcome Measures

Name	Time	Method
Length of Hospitalization	estimated one week or less	the length of the patient's in-hospital stay following admission for Nuss procedure

Secondary Outcome Measures

Name	Time	Method
Cost Analysis	estimated one week	cost analysis of initial hospitalization following Nuss procedure
Narcotic Usage	Post Operative Hospital Stay	Inpatient narcotic usage
Mean Neuropathic Pain Score at One Year	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).