|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00804674 |
|
Date of registration:
|
03/12/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap
|
|
Scientific title:
|
Improved Pain Relief Using Intermittent Bupivacain Injections at the Donor Site After Breast Reconstruction With Deep Inferior Epigastric Artery Perforator (DIEP) Flap |
|
Date of first enrolment:
|
August 2005 |
|
Target sample size:
|
47 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00804674 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
|
|
|
Contacts
|
|
Name:
|
jørgen utvoll, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Consultant at ullevaal university hospital |
| | |
|
Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Reconstruction
|
|
Intervention(s)
|
|
Drug: bupivacain
|
|
Drug: placebo
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|