Pain Management for Pectus Excavatum Repair

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Epidural Analgesia; Drug: Patient-Controlled IV Analgesia

• Registration Number: NCT00413582
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

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.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2010-05
• Study Completion: 2010-10
• Status Verified: 2011-12
• Results First Submitted: 2011-12-12
• Results First Submitted QC: 2011-12-12
• Last Update Submitted: 2011-12-12
• Results First Posted: 2012-01-16
• Last Update Posted: 2012-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Epidural Analgesia	Epidural analgesia
2	Patient-Controlled IV Analgesia	IV narcotic analgesia

Primary Outcome Measures

Name	Time	Method
Length of Hospitalization	1 week

Secondary Outcome Measures

Name	Time	Method
Time in the Operating Room	1 week

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States