Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT01863498 |
| Other study ID # |
12120535 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2013 |
| Est. completion date |
August 2019 |
Study information
| Verified date |
August 2020 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000
children. Operative repair of the anterior thoracic concavity has transitioned to the
minimally invasive approach with substernal bar placement through small axillary incisions
(Nuss procedure and multiple modifications). These procedures were quickly incorporated by
high volume centers around the world including our own. The operation is certainly quicker
and associated with less blood loss than the open operation, but as opposed to most minimally
invasive versions of an operation, patients do not leave the hospital sooner after bar
placement and experience more post-operative pain.
Pain during the post-operative hospital stay is the dominant management issue after bar
placement. The sparse literature on the topic has suggested that a thoracic epidural is the
most effective means for attenuating the pain during the first few post-operative days.
Therefore, most centers approach all patients undergoing a pectus deformity repair with an
attempt at epidural placement under the assumption that this provides the most effective
strategy for pain control.
However, the investigators conducted a retrospective evaluation to examine the validity of
this assumption and to investigate whether there is a role for a prospective study to
determine the optimum post-operative pain management of these patients. The results
demonstrate there was a decreased length of stay in the patients not treated with an epidural
(PCA), despite no disadvantage in pain control. Further, 30% in whom an epidural was
attempted, catheter placement failed.
This data certainly challenges the assumption that an epidural is the optimum management for
these patients, and convincingly answers the question as to whether there is a role for a
prospective randomized trial.
Description:
Pectus excavatum, the most common chest wall deformity, occurs in roughly one in 1000
children.1 Operative repair of the anterior thoracic concavity has transitioned to the
minimally invasive approach with substernal bar placement through small axillary incisions
(Nuss procedure and multiple modifications). These procedures were quickly incorporated by
high volume centers around the world including our own.2-7 The operation is certainly quicker
and associated with less blood loss than the open operation, but as opposed to most minimally
invasive versions of an operation, patients do not leave the hospital sooner after bar
placement and experience more post-operative pain.6,7,8 Pain during the post-operative
hospital stay is the dominant management issue after bar placement. The sparse literature on
the topic has suggested that a thoracic epidural is the most effective means for attenuating
the pain during the first few post-operative days.10-12 Therefore; most centers approach all
patients undergoing a pectus deformity repair with an attempt at epidural placement under the
assumption that this provides the most effective strategy for pain control.3-9, 13 However,
the investigator conducted a retrospective evaluation to examine the validity of this
assumption and to investigate whether there is a role for a prospective study to determine
the optimum post-operative pain management of these patients.14 The investigator found length
of stay was shorter with PCA and pain scores were similar. What the investigator found
certainly challenges the assumption that an epidural is the optimum management for these
patients, and convincingly answered the question as to whether there is a role for a
prospective randomized trial.
The investigator conducted the prospective, randomized trial in 110 patients.15 The
investigator found the pain scores were better with epidural for the first 2 days and better
with PCA the last 2 days. There was no difference in length of stay although it trended to
favor PCA. Epidural group incurred far greater operation times and charges. The pragmatic
interpretation was that the investigator should just use PCA. The anesthesia interpretation
is that the investigator need a better epidural. Therefore, the investigator have developed a
better protocol for the transition to try to improve pain control the last 2 days. Further,
the investigator recognize several flaws in the last study; the investigator included
patients at extremes of age which don't represent a normal course. Second, the investigator
kept patients in the hospital until they had a bowel movement which may have prolonged the
care unnecessarily in the PCA group. The investigator will use the same sample size as last
time since the difference in length of stay the investigator were designed to detect was more
than a day which is clinically relevant.
