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Paravertebral Block for Breast Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131170
First Posted: August 17, 2005
Last Update Posted: July 6, 2007
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.
Information provided by:
University of Aarhus
  Purpose
The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Condition Intervention Phase
Breast Cancer Procedure: paravertebral block Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Dosage of analgesic [ Time Frame: 1 day ]

Enrollment: 90
Study Start Date: September 2005
Study Completion Date: September 2006
Detailed Description:
Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast surgery

Exclusion Criteria:

  • Infections
  • Coagulation disorder
  • Allergy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00131170


Locations
Denmark
Dept of Anesthesiology, Aarhus University Hospital
Aarhus, Denmark, DK 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Palle Carlsson, MD Dr Sci Dept anesthesiology, Arhus University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00131170     History of Changes
Other Study ID Numbers: PVB1
First Submitted: August 15, 2005
First Posted: August 17, 2005
Last Update Posted: July 6, 2007
Last Verified: July 2007