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

This study has been completed.

First Received: December 3, 2008 Last Updated: December 8, 2008 History of Changes

Sponsored by:	Ullevaal University Hospital
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00804674

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 II

MedlinePlus related topics: Breast Reconstruction

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	Improved Pain Relief Using Intermittent Bupivacain Injections at the Donor Site After Breast Reconstruction With Deep Inferior Epigastric Artery Perforator (DIEP) Flap

Further study details as provided by Ullevaal 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
1 bupivacain: Active Comparator	Drug: bupivacain
2 placebo: Placebo Comparator	Drug: placebo

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804674

Sponsors and Collaborators

Ullevaal University Hospital

Investigators

Principal Investigator:

jørgen utvoll, MD

Consultant at ullevaal university hospital

More Information

No publications provided

Responsible Party:	ullevaal university hospital ( Jørgen Utvoll MD )
Study ID Numbers:	01
Study First Received:	December 3, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00804674 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Ullevaal University Hospital:

bupivacain
breast
reconstruction
diep

pain
postoperative
catheter
anesthesia

Study placed in the following topic categories:

Central Nervous System Depressants
Anesthetics
Bupivacaine

Pain
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Bupivacaine
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009