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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

Page last updated: October 04, 2010

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