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Comparison of Two Different Procedures for Plexus Anesthesia

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.
 
ClinicalTrials.gov Identifier: NCT00151112
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 11, 2008
Sponsor:
Information provided by:
University Hospital Muenster

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date September 11, 2008
Study Start Date  ICMJE September 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2007)
  • Extent of anesthesia [ Time Frame: 20 minutes after acillary plexus block ]
  • Efficacy of anesthesia [ Time Frame: 20 minutes after axillary plexus block ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • Extent of anesthesia at 20 minutes
  • Efficacy of anesthesia at 20 minutes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2007)		 Rate of failure [ Time Frame: 20 minutes after axillary plexus block ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)		 rate of failure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Different Procedures for Plexus Anesthesia
Official Title  ICMJE Comparison of Two Different Procedures for Plexus Anesthesia: Standard Position Versus Combination of Lateral Position and 20° Trendelenburg Position
Brief Summary The purpose of this study is to investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° Trendelenburg positioning.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Wounds and Injuries
Intervention  ICMJE Procedure: Positioning and plexus anesthesia
positioning during plexus anesthesia
Study Arms  ICMJE
  • Experimental: 1
    combination of lateral position and 20° Trendelenburg Position
    Intervention: Procedure: Positioning and plexus anesthesia
  • Active Comparator: 2
    standard positioning
    Intervention: Procedure: Positioning and plexus anesthesia
Publications * Bullmann V, Waurick R, Rodl R, Hulskamp G, Orlowski O, van Aken H, Winkelmann W, Weber TP. [Corrective osteotomy of the humerus using perivascular axillary anesthesia according to Weber in a patient suffering from McCune-Albright syndrome]. Anaesthesist. 2005 Sep;54(9):889-94. doi: 10.1007/s00101-005-0874-6. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2005)		 100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Single shot axillary block

Exclusion Criteria:

  • Lateral position not possible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151112
Other Study ID Numbers  ICMJE 01-Anast-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Principle Investigator: T. Weber, MD, Department of Anesthesiology and Intensive Care, University Hospital Muenster
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University Hospital Muenster
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Weber, MD Department of Anesthesiology and Intensive Care, University Hospital Münster
PRS Account University Hospital Muenster
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP