Mininimum Effective Anaesthetic Volume of Local AnaestheticNCT01956617
The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
A study testing lumbar plexus block in people with Mininimum Effective Anaesthetic Volume of Local Anaesthetic, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Mininimum Effective Anaesthetic Volume of Local Anaesthetic
- What is being tested?
- lumbar plexus block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesNorway
- Study dates
- Oct 2013to May 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- orthopaedic patients scheduled for elective hip and knee arthoroplasty
- ASA 1 - 2 or stable ASA 3
- age between 18 and 70 years
- good ability to communicate and to cooperate
Who cannot join
- ASA > 3 or unstable ASA 3
- BMI > 32
- chronicle pain
- nephrological diseases or nephropathy
- known contraindications against the use of local anaesthetics
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Anaesthesia and Intensive Care Medicine, Oslo University Hospital
Oslo, Oslo, 0027
Oslo University Hospital
Oslo, Oslo, 0488
About this study
The "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method study design, 30 patients scheduled for elective total hip and knee arthroplasty will be included in the study.
- Being tested
- lumbar plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar plexus blockOther
| Study group | Role | What they receive |
|---|---|---|
| injection volume | Other | block success or failure determines a 5 ml decrease or increase for the subsequent patient, respectively Receives: Other: lumbar plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimum effective volume
The primary outcome measure (MEV) is based on 30 measurements in 30 patients (secondary outcome measure: block success). MEV is determined by Dixon and Massey up-and-down method when all patients have been tested in the study
Measured: from day 1 up to 20 weeks
Secondary outcomes (1)
block success
45 minutes after lumbar plexus blockade was performed
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2014
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 Mininimum Effective Anaesthetic Volume of Local AnaestheticStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Rudolf Sauter, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956617
- Sponsor's protocol ID
- 2013/1328-3
- Status last verified
- Jun 2014
- First submitted
- 26 Sep 2013
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
PubMed 26426575
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mininimum Effective Anaesthetic Volume of Local Anaesthetic in Ultrasound-guided "Shamrock" Lumbar Plexus Block
- ClinicalTrials.gov ID
- NCT01956617
- Acronym / sponsor ID
- 2013/1328-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2014 (actual)
- First posted
- 8 Oct 2013 (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 "Shamrock method" is a new ultrasound-guided lumbar plexus block. The aim of the study is to determine the minimum effective volume of ropivacaine 0.5% required to produce an effective lumbar plexus block with this method. Using the Dixon and Massey up-and-down method study design, 30 patients scheduled for elective total hip and knee arthroplasty will be included in the study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| injection volume | Other | Other: lumbar plexus blockblock success or failure determines a 5 ml decrease or increase for the subsequent patient, respectively |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- orthopaedic patients scheduled for elective hip and knee arthoroplasty
- ASA 1 - 2 or stable ASA 3
- age between 18 and 70 years
- good ability to communicate and to cooperate
Key exclusion criteria (6 listed)
- ASA > 3 or unstable ASA 3
- BMI > 32
- chronicle pain
- nephrological diseases or nephropathy
- known contraindications against the use of local anaesthetics
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 |
|---|---|---|
| lumbar plexus block | Other | injection volume |
Primary outcome
minimum effective volume
Time frame: from day 1 up to 20 weeks
The primary outcome measure (MEV) is based on 30 measurements in 30 patients (secondary outcome measure: block success). MEV is determined by Dixon and Massey up-and-down method when all patients have been tested in the study
1 secondary outcome
block success
Time frame: Day 1
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 23 Jun 2014.
- Derived from this study: PubMed 26426575Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar plexus block in people with Mininimum Effective Anaesthetic Volume of Local Anaesthetic, run by Oslo University Hospital at 2 sites in Norway.
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 4 inclusion and 6 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 23 Jun 2014. 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 Norway. 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?
minimum effective volume (time frame: from day 1 up to 20 weeks). 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 NCT01956617, 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 23 Jun 2014.