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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00403013
First received: November 22, 2006
Last updated: July 3, 2009
Last verified: July 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
lateral, head-down position during axillary plexus block
Procedure: Positioning and anesthesia
Positioning during axillary plexus block
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Anesthesiology and Intensive Care, University Hospital Muenster
Muenster, Germany, D-48129
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: T Weber, MD Department of Anesthesiology and Intensive Care, University Hospital Muenster
  More Information

Publications:
Responsible Party: Principle Investigator, Department of Anesthesiology and Intensive Care, University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00403013     History of Changes
Other Study ID Numbers: 01-AnIt-06
Study First Received: November 22, 2006
Last Updated: July 3, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
nerve block/*methods
Anesthetics, Local/pharmacokinetics
*Brachial Plexus

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014