Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap

Phase 2

Completed

• Conditions: Breast Reconstruction
• Interventions: Drug: placebo; Drug: bupivacain

• Registration Number: NCT00804674
• Lead Sponsor: Ullevaal University Hospital

Brief Summary

patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

• all patients planned to undergo reconstructive breast surgery with a DIEP

Exclusion Criteria

• regular use of analgesics
• known allergic reaction to bupivacain
• bleeding disorders
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 placebo	placebo	-
1 bupivacain	bupivacain	-