Cryoanalgesia vs. Epidural in the Nuss Procedure

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.

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