Pain Management for Pectus Excavatum Repair

Postoperative Pain Clinical Trial

Official title: Prospective Randomized Trial: Pain Management Strategy After Pectus Excavatum Repair

Status Completed

Clinical Trial 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 Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Funnel Chest
• Pain, Postoperative
• Postoperative Pain

• NCT number: NCT00413582
• Study type: Interventional
• Source: Children's Mercy Hospital Kansas City
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Completion date: October 2010