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

Breast Reconstruction Clinical Trial

Official title:

Improved Pain Relief Using Intermittent Bupivacain Injections at the Donor Site After Breast Reconstruction With Deep Inferior Epigastric Artery Perforator (DIEP) Flap

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804674
• Other study ID #: 01
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2008
• Last updated: June 30, 2011
• Start date: August 2005
• Est. completion date: May 2007

Study information

• Verified date: June 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Drug:
• bupivacain

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital