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

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. Identifier: NCT00804674
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : July 1, 2011
Information provided by:
Oslo 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

Condition or disease Intervention/treatment Phase
Breast Reconstruction Drug: bupivacain Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
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
Study Start Date : August 2005
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 bupivacain Drug: bupivacain
Placebo Comparator: 2 placebo Drug: placebo

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

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

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 identifier (NCT number): NCT00804674

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

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

Keywords provided by Oslo University Hospital:

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