Pain Management for Pectus Excavatum Repair
| Status: | Archived |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair
The objective of this study is to scientifically evaluate two different management
strategies for post-operative pain after pectus excavatum repair.
The hypothesis is that pain management without an epidural decreases hospital stay without
compromising comfort.
The primary outcome variable is length of hospitalization after the intervention.
This will be a single institution, prospective, randomized clinical trial involving patients
who undergo the minimally invasive repair of a pectus excavatum deformity with bar
placement. This is intended to be a definitive study.
Power calculations based on the known length of hospitalization listed above with α = 0.05
and power of 0.8 show the need for 55 patients in each arm. The primary end point will be
reached during the hospital stay; therefore, we expect a very small amount of attrition and
will intend to recruit 110. One group will undergo an attempt for epidural regional
analgesia (epidural) for post-operative pain control. The other groups will receive patient
controlled intravenous systemic analgesia (PCA).
Both groups will have the same management algorithm. All data will be analyzed on
intention-to-treat basis.
We found this trial at
1
site
Children's Memorial Hospital, Chicago Ann & Robert H. Lurie Children
Click here to add this to my saved trials
