Shoulder SurgeryNCT00403013
Plexus Anesthesia in Lateral, Head-Down Position for Elective Surgery of the Shoulder
A study testing Positioning and anesthesia in people with Shoulder Surgery, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- Positioning and anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective surgery of the shoulder
Who cannot join
- lateral, head down position not possible
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care, University Hospital Muenster
Münster, D-48129
About this study
Official title: Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position
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.
- Conditions
- Shoulder Surgery
- Being tested
- Positioning and anesthesia
- Keywords
- nerve block/*methods, Anesthetics, Local/pharmacokinetics, *Brachial Plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning and anesthesiaProcedure or surgery
Positioning during axillary plexus block
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | lateral, head-down position during axillary plexus block Receives: Procedure: Positioning and anesthesia |
| 2 | Active comparator | standard position during axillary plexus block Receives: Procedure: Positioning and anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score
Measured: 8 hours after start of axillary plexus block
VAS Score
Measured: 24 hours after start of axillary plexus block
Secondary outcomes (3)
Opioid consumption
Measured: intraoperatively
Patient comfort
Measured: six months after surgery
Opioid consumption
Measured: during hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- T Weber, MD, Principal investigator, Department of Anesthesiology and Intensive Care, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403013
- Sponsor's protocol ID
- 01-AnIt-06
- Status last verified
- Jul 2009
- First submitted
- 22 Nov 2006
- Last updated
- 7 Jul 2009
- Results posted
- No
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. doi: 10.1111/j.1365-2044.2006.04618.x.
PubMed 16704585
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Plexus Block for Perioperative Analgesia in Patients Scheduled for Elective Surgery of the Shoulder: Influence of Lateral, Head-Down Position
- ClinicalTrials.gov ID
- NCT00403013
- Acronym / sponsor ID
- 01-AnIt-06
- Conditions
- Shoulder Surgery
- Keywords
- nerve block/*methods, Anesthetics, Local/pharmacokinetics, *Brachial Plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Positioning and anesthesialateral, head-down position during axillary plexus block |
| 2 | Active comparator | Procedure: Positioning and anesthesiastandard position during axillary plexus block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for elective surgery of the shoulder
Key exclusion criteria (1 listed)
- lateral, head down position not possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positioning and anesthesiaPositioning during axillary plexus block | Procedure or surgery | 1, 2 |
Primary outcome
Visual Analog Scale (VAS) score
Time frame: 8 hours after start of axillary plexus block
VAS Score
Time frame: 24 hours after start of axillary plexus block
3 secondary outcomes
Opioid consumption
Time frame: intraoperatively
Patient comfort
Time frame: six months after surgery
Opioid consumption
Time frame: during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
- Background: PubMed 16704585Orlowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T Weber, MD principal investigator
Department of Anesthesiology and Intensive Care, University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning and anesthesia in people with Shoulder Surgery, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) score (time frame: 8 hours after start of axillary plexus block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.