Kansas City, Missouri 64108

  • Postoperative Pain

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients undergoing a pectus excavatum repair with bar placement. Exclusion Criteria: - Open repair - Re-Do operation - Known allergy to a pain medication in the protocol - Existing contraindications to epidural catheter placement - Requirement for 2 bars to be placed (rare) - Inadequate baseline cognitive function to understand/respond to VAS questionnaire


NCT ID:

NCT00413582


Primary Contact:

Principal Investigator
Shawn D St. Peter, MD
Children's Mercy Hospital

Shawn D St. Peter, MD
Phone: (816)234-3575 ext. 6465
Email: sspeter@cmh.edu


Backup Contact:

Email: swsharp@cmh.edu
Susan W Sharp, PhD
Phone: (816)234-3575 ext. 6670


Location Contact:

Kansas City, Missouri 64108
United States

Shawn D St. Peter, MD
Phone: 816-234-3575
Email: sspeter@cmh.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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