Pain Management for Pectus Excavatum Repair
Information source: Children's Mercy Hospital Kansas City
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Epidural Analgesia (Drug); Patient-Controlled IV Analgesia (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Children's Mercy Hospital Kansas City Official(s) and/or principal investigator(s):
Shawn D St. Peter, MD, Principal Investigator, Affiliation: Children's Mercy Hospital
Overall contact:
Shawn D St. Peter, MD, Phone: (816)234-3575, Ext: 6465, Email: sspeter@cmh.edu
Summary
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.
Clinical Details
Official title: Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Length of hospitalization
Secondary outcome: Time in the operating room, time to urinary catheter removal, time to regular diet, time to removal of oxygen support, time to transition to oral pain meds
Detailed description:
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.
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Shawn D St. Peter, MD, Phone: (816)234-3575, Ext: 6465, Email: sspeter@cmh.edu
Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Shawn D St. Peter, MD, Phone: 816-234-3575, Ext: 6465, Email: sspeter@cmh.edu
Shawn D St. Peter, MD, Principal Investigator
Kathy A Weesner, MD, Sub-Investigator
Susan W Sharp, PhD, Sub-Investigator
Additional Information
Starting date: October 2006
Last updated: February 5, 2010
|
