NCT00403013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

1.7 years

First QC Date

November 22, 2006

Last Update Submit

July 3, 2009

Conditions

Shoulder Surgery

Keywords

nerve block/*methodsAnesthetics, Local/pharmacokinetics*Brachial Plexus

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS) score

    8 hours after start of axillary plexus block

  • VAS Score

    24 hours after start of axillary plexus block

Secondary Outcomes (3)

  • Opioid consumption

    intraoperatively

  • Patient comfort

    six months after surgery

  • Opioid consumption

    during hospital stay

Study Arms (2)

1

EXPERIMENTAL

lateral, head-down position during axillary plexus block

Procedure: Positioning and anesthesia

2

ACTIVE COMPARATOR

standard position during axillary plexus block

Procedure: Positioning and anesthesia

Interventions

Positioning and anesthesiaPROCEDURE

Positioning during axillary plexus block

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for elective surgery of the shoulder

You may not qualify if:

  • lateral, head down position not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, University Hospital Muenster

Münster, D-48129, Germany

Location

Related Publications (1)

  • 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. doi: 10.1111/j.1365-2044.2006.04618.x.

    PMID: 16704585BACKGROUND

MeSH Terms

Interventions

Patient PositioningAnesthesia

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesAnesthesia and Analgesia

Study Officials

  • T Weber, MD

    Department of Anesthesiology and Intensive Care, University Hospital Muenster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

April 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

DE(1)