Wounds and InjuriesNCT00151112
Comparison of Two Different Procedures for Plexus Anesthesia
A study testing Positioning and plexus anesthesia in people with Wounds and Injuries, run by University Hospital Muenster at 2 sites in Germany.
Trial summary
The purpose of this study is to investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° Trendelenburg positioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Positioning and plexus anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2005to Aug 2008
- 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
- Single shot axillary block
Who cannot join
- Lateral position not possible
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, D-48149
BG Unfallklinik Murnau; Department of Anesthesiology
Murnau am Staffelsee, D-82418
About this study
Official title: Comparison of Two Different Procedures for Plexus Anesthesia: Standard Position Versus Combination of Lateral Position and 20° Trendelenburg Position
The purpose of this study is to investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° Trendelenburg positioning.
- Conditions
- Wounds and Injuries
- Being tested
- Positioning and plexus anesthesia
- Keywords
- nerve block, regional anesthesia, injuries, diverse malformations
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning and plexus anesthesiaProcedure or surgery
positioning during plexus anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | combination of lateral position and 20° Trendelenburg Position Receives: Procedure: Positioning and plexus anesthesia |
| 2 | Active comparator | standard positioning Receives: Procedure: Positioning and plexus anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of anesthesia
Measured: 20 minutes after acillary plexus block
Efficacy of anesthesia
Measured: 20 minutes after axillary plexus block
Secondary outcomes (1)
Rate of failure
Measured: 20 minutes after axillary plexus block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2008
- Study completionAug 2008
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 Wounds and InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Weber, MD, Principal investigator, Department of Anesthesiology and Intensive Care, University Hospital Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151112
- Sponsor's protocol ID
- 01-Anast-05
- Status last verified
- Sep 2008
- First submitted
- 7 Sep 2005
- Last updated
- 11 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bullmann V, Waurick R, Rodl R, Hulskamp G, Orlowski O, van Aken H, Winkelmann W, Weber TP. [Corrective osteotomy of the humerus using perivascular axillary anesthesia according to Weber in a patient suffering from McCune-Albright syndrome]. Anaesthesist. 2005 Sep;54(9):889-94. doi: 10.1007/s00101-005-0874-6. German.
PubMed 15947897
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Procedures for Plexus Anesthesia: Standard Position Versus Combination of Lateral Position and 20° Trendelenburg Position
- ClinicalTrials.gov ID
- NCT00151112
- Acronym / sponsor ID
- 01-Anast-05
- Conditions
- Wounds and Injuries
- Keywords
- nerve block, regional anesthesia, injuries, diverse malformations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Sep 2005 (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 investigate the influence of difference positioning on extension and efficacy of brachial plexus anesthesia at 20 minutes by using the axillary plexus block with supine positioning and a lateral positioning onto the non-anaesthetized side, combined with 20° Trendelenburg positioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Positioning and plexus anesthesiacombination of lateral position and 20° Trendelenburg Position |
| 2 | Active comparator | Procedure: Positioning and plexus anesthesiastandard positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Single shot axillary block
Key exclusion criteria (1 listed)
- Lateral 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 plexus anesthesiapositioning during plexus anesthesia | Procedure or surgery | 1, 2 |
Primary outcome
Extent of anesthesia
Time frame: 20 minutes after acillary plexus block
Efficacy of anesthesia
Time frame: 20 minutes after axillary plexus block
1 secondary outcome
Rate of failure
Time frame: 20 minutes after axillary plexus block
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 11 Sep 2008.
- Background: PubMed 15947897Bullmann V, Waurick R, Rodl R, Hulskamp G, Orlowski O, van Aken H, Winkelmann W, Weber TP. [Corrective osteotomy of the humerus using perivascular axillary anesthesia according to Weber in a patient suffering from McCune-Albright syndrome]. Anaesthesist. 2005 Sep;54(9):889-94. doi: 10.1007/s00101-005-0874-6. German.
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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.
Thomas Weber, MD principal investigator
Department of Anesthesiology and Intensive Care, University Hospital Münster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning and plexus anesthesia in people with Wounds and Injuries, run by University Hospital Muenster at 2 sites 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 11 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Extent of anesthesia (time frame: 20 minutes after acillary 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 NCT00151112, 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 11 Sep 2008.