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

This study has been completed.
Information provided by:
Oslo University Hospital Identifier:
First received: December 3, 2008
Last updated: June 30, 2011
Last verified: June 2011
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: Double Blind (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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00804674

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

Responsible Party: Jørgen Utvoll MD, ullevaal university hospital Identifier: NCT00804674     History of Changes
Other Study ID Numbers: 01
Study First Received: December 3, 2008
Last Updated: June 30, 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 processed this record on August 16, 2017