Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder - Full Text View

Purpose

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.

Condition	Intervention
Shoulder Surgery	Procedure: Positioning and anesthesia

MedlinePlus related topics:

Anesthesia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Visual Analog Scale (VAS) score [ Time Frame: 8 hours after start of axillary plexus block ] [ Designated as safety issue: No ]
VAS Score [ Time Frame: 24 hours after start of axillary plexus block ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Opioid consumption [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
Patient comfort [ Time Frame: six months after surgery ] [ Designated as safety issue: No ]
Opioid consumption [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental lateral, head-down position during axillary plexus block	Procedure: Positioning and anesthesia Positioning during axillary plexus block
2: Active Comparator standard position during axillary plexus block	Procedure: Positioning and anesthesia Positioning during axillary plexus block

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients scheduled for elective surgery of the shoulder

Exclusion Criteria:

lateral, head down position not possible

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403013

Contacts


Contact: R Waurick, MD	+49-251-834-7255	waurick@uni-muenster.de

Locations


Germany
	Department of Anesthesiology and Intensive Care, University Hospital Muenster	Recruiting
	Muenster, Germany, D-48129
	Contact: R Waurick, MD +49-251-834-7255 waurick@anit.uni-muenster.de
	Contact: P Engel, MD +49-251-834-7255 engelp@uni-muenster.de
	Principal Investigator: R Waurick, MD
	Sub-Investigator: P Engel, MD

Sponsors and Collaborators

University Hospital Muenster

Investigators


Principal Investigator:	T Weber, MD	Department of Anesthesiology and Intensive Care, University Hospital Muenster

More Information

Publications:

Orlowski O, Bullmann V, Vieth V, Filler T, Osada N, Van Aken H, Weber TP. Perivascular axillary brachial plexus block and patient positioning: the influence of a lateral, head-down position. Anaesthesia. 2006 Jun;61(6):528-34.

Responsible Party:	Department of Anesthesiology and Intensive Care, University Hospital Muenster ( Principle Investigator )
Study ID Numbers:	01-AnIt-06
First Received:	November 22, 2006
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00403013
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Muenster:

nerve block/*methods

Anesthetics, Local/pharmacokinetics

*Brachial Plexus

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00403013