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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804674
First Posted: December 9, 2008
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose
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

Condition Intervention Phase
Breast Reconstruction Drug: bupivacain Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Improved Pain Relief Using Intermittent Bupivacain Injections at the Donor Site After Breast Reconstruction With Deep Inferior Epigastric Artery Perforator (DIEP) Flap

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Enrollment: 47
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 bupivacain Drug: bupivacain
Placebo Comparator: 2 placebo Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804674


Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: jørgen utvoll, MD Consultant at ullevaal university hospital
  More Information

Responsible Party: Jørgen Utvoll MD, ullevaal university hospital
ClinicalTrials.gov Identifier: NCT00804674     History of Changes
Other Study ID Numbers: 01
First Submitted: December 3, 2008
First Posted: December 9, 2008
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by Oslo University Hospital:
bupivacain
breast
reconstruction
diep
pain
postoperative
catheter
anesthesia

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents