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Sponsored by: |
Ullevaal University Hospital |
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Information provided by: | Ullevaal University Hospital |
ClinicalTrials.gov Identifier: | NCT00804674 |
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 |
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 |
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 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
bupivacain breast reconstruction diep |
pain postoperative catheter anesthesia |
Central Nervous System Depressants Anesthetics Bupivacaine |
Pain Peripheral Nervous System Agents Anesthetics, Local |
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 |