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

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Completed
• CT.gov ID: NCT00403013
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Surgery	Procedure: Positioning and anesthesia	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scale (VAS) score [8 hours after start of axillary plexus block]

2. VAS Score [24 hours after start of axillary plexus block]

Secondary Outcome Measures

1. Opioid consumption [intraoperatively]

2. Patient comfort [six months after surgery]

3. Opioid consumption [during hospital stay]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients scheduled for elective surgery of the shoulder

Exclusion Criteria:

• lateral, head down position not possible

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00403013
• Other Study ID Numbers: 01-AnIt-06
• First Posted: Nov 23, 2006
• Last Update Posted: Jul 7, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: nerve block/*methods; Anesthetics, Local/pharmacokinetics; *Brachial Plexus
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Jul 7, 2009