SPAIN Chest Wall Deformity Project (Pectus Repair)

Context: Chest wall deformities in children are relatively common. One such deformity, known
as Pectus Excavatum (PE), involves a concavity of the chest and is the most frequent of these
abnormalities - present in approximately 1 out of every 400-1000births. This deformity is
often a cosmetic problem for affected individuals. When severe, PE can also be associated
with cardiopulmonary compromise.

Treatment of PE involves surgical correction. There are several potential methods for
correcting PE. In the past the most common repair involved an open procedure which involves
excision and reshaping of the ribcage. More recently a minimally invasive procedure has been
adopted involving the placement of a stainless steel or titanium bar underneath the sternum
to reshape the chest wall. This procedure, commonly known as the Nuss procedure, carries with
it significant post-operative pain management problems. In fact the pain issues after Nuss
procedure may be more significant than after open repair. The quality of postoperative pain
control in these cases has been shown to affect several measurable objective outcomes during
hospitalization including capacity for deep breathing, early mobilization, ambulation, and
length of hospital stay.

Epidural analgesia (EA) has been one of the standard methods for managing pain in the early
postoperative period after PE repair. Unfortunately severe pain may persist after the removal
of an epidural catheter resulting in a difficult "transition" period just prior to discharge
from the hospital. In addition reports of neurological injury after epidural analgesia for
Nuss procedures have appeared. In light of these issues, many institutions have opted for
alternative methods of pain control including peripheral nerve blocks, patient controlled
analgesia, and wound catheters. There remains significant debate as to which pain control
methodology is best. There is little consistent data available on pain control or outcomes
that occur after EA is stopped. Moreover there is reluctance in any one institution to trial
or randomize patients to a variety of treatment modalities. For all of these reasons,
investigators are proposing participation in a multi-institutional data sharing project
concerning the repair of EA in which participating centers will collaborate to better
understand the outcomes of perioperative care for patients undergoing correction of this
problem.

The primary objective is to create a multicenter registry which captures data relating to the
perioperative course and management of children undergoing PE repair surgery. This effort is
undertaken in order to augment safety and quality improvement activities at participating
sites. Investigators understand that there are multiple methodologies for accomplishing the
anesthesia and perioperative pain control for this surgery. There is little comparative data
on the outcomes from the different possible management strategies. Given the relative
frequencies of these surgeries where few centers perform more than 20-50 of these procedures
per year, it is not practical for any one (or two) centers to study this procedure in an
observational manner or a controlled randomized trial. Investigators' aggregate
multi-institutional data set will be used for benchmarking for both local and national safety
and quality improvement efforts. Participating sites will be provided with reports comparing
the local site to the aggregate dataset for specific perioperative outcome variables (e.g.
pain metrics) and factors that could be associated with improved outcomes. Outcome variables
include but are not limited to intraoperative hemodynamics, pain control, emergence
agitation, apnea/airway obstruction, hemodynamic stability, time to first ambulation, pain
scores while in the hospital, total hospital days, time to school or work attendance, and
symptoms of post-traumatic stress.

Secondary objective: Investigators will ultimately look at the relationship between specific
management metrics such as the use of epidural anesthesia vs. peripheral nerve blocks vs.
local anesthesia wound infiltration and our primary outcome metrics. In addition
Investigators will consider the frequency of long term Post Traumatic Stress behaviors and
the various measures of pain control in the perioperative period.

Study Design:

Basic design: Prospective observational multicenter data registry

Setting/Participants:

- Patients ages 8 to 30 years undergoing surgery for Pectus Excavatum Repair in a hospital
setting

- Up to 20 hospital sites

Data Collection, Storage and Release:

The registry will capture data relating to the perioperative management of children
undergoing PE repair. Measures will include demographic data, data on degree of deformity,
perioperative management, intraoperative management, hospital course, surgical technique,
complications, and long term pain/psychological outcomes.

Inclusion Criteria:

- Males and females ages 8 to 30 years.

- Undergoing surgical procedures on the chest wall region performed to correct Pectus
Excavatum deformities.

Exclusion Criteria: