- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403013
Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder
July 3, 2009 updated by: University Hospital Muenster
Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position
The purpose of this study is to determine whether the axillary plexus block performed in lateral, head down position is effective in the perioperative analgesia in patients scheduled for elective surgery of the shoulder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Muenster, Germany, D-48129
- Department of Anesthesiology and Intensive Care, University Hospital Muenster
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients scheduled for elective surgery of the shoulder
Exclusion Criteria:
- lateral, head down position not possible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
lateral, head-down position during axillary plexus block
|
Positioning during axillary plexus block
|
Active Comparator: 2
standard position during axillary plexus block
|
Positioning during axillary plexus block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analog Scale (VAS) score
Time Frame: 8 hours after start of axillary plexus block
|
8 hours after start of axillary plexus block
|
VAS Score
Time Frame: 24 hours after start of axillary plexus block
|
24 hours after start of axillary plexus block
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Opioid consumption
Time Frame: intraoperatively
|
intraoperatively
|
Patient comfort
Time Frame: six months after surgery
|
six months after surgery
|
Opioid consumption
Time Frame: during hospital stay
|
during hospital stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: T Weber, MD, Department of Anesthesiology and Intensive Care, University Hospital Muenster
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
November 22, 2006
First Submitted That Met QC Criteria
November 22, 2006
First Posted (Estimate)
November 23, 2006
Study Record Updates
Last Update Posted (Estimate)
July 7, 2009
Last Update Submitted That Met QC Criteria
July 3, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-AnIt-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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