Hip FracturesPhase 4NCT02255591
Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus
A Phase 4 study testing Lidocaine-adrenaline added gadolinium. in people with Hip Fractures and Anesthesia Local, run by University of Aarhus at 1 site in Denmark.
Trial summary
The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Anesthesia Local, Pain, Postoperative
- What is being tested?
- Lidocaine-adrenaline added gadolinium.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Mar 2015
- Phase
- Phase 4
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age ≥ 18 years
- Volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol
- Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)
Who cannot join
- Volunteers not able to cooperate for the study
- Volunteers not able to understand Danish
- Daily use of analgesics
- Allergy against the medicines used in the study
- Drug abuse (according to the investigator's judgement)
- Alcohol consumption larger than the recommendations of the Danish National Board of Health
Show all 9Show fewer
- Volunteers in whom nerve blocks are not possible due to technical reasons
- Volunteers who meet any contraindication for MRI including claustrophobia
- Volunteers who are incompetent, i.e. surrogate consent is not accepted
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital
Aarhus C, DK-8000
About this study
Official title: Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial
The main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers.
Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers.
The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident technique.
- Conditions
- Hip Fractures, Anesthesia Local, Pain, Postoperative
- Being tested
- Lidocaine-adrenaline added gadolinium.
- Keywords
- Hip surgery anesthesia, Perioperative analgesia
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine-adrenaline added gadolinium.Drug
| Study group | Role | What they receive |
|---|---|---|
| Shamrock | Experimental | Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium. Receives: Drug: Lidocaine-adrenaline added gadolinium. |
| Lumbar Ultrasound Trident | Active comparator | Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium. Receives: Drug: Lidocaine-adrenaline added gadolinium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block performance time
Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.
Measured: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Secondary outcomes (15)
Number of needle feeds
Needle feeds are defined as retraction of needle followed by new feed of the needle disregarding the number of skin punctures.
Measured: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Discomfort during block placement
Discomfort is measured with Numeric Rating Scale (NRS).
Measured: Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.
Plasma Lidocaine
Measured: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Mear arterial pressure
Measured: Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Cost-effectiveness
Cost-effectiveness estimated as extra expense per successful lumbar plexus block and calculated as incremental cost-effectiveness ratio (ICER).
Measured: Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.
Sensor block
Sensor block (cold, warm, touch, and pain) of the dermatomes T8-S3 and of the femoral nerve and the lateral femoral cutaneous nerve.
Measured: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Motor block
Motor block of the femoral nerve (knee extension), the obturator nerve (hip adduction), the superior gluteal nerve (hip abduction), and the sciatic nerve (knee flexion) estimated as active resistance against movement of the relevant joint and with sphygmomanometer of the relevant joint as maximal voluntary isometric contraction with dynamometer (mmHg).
Measured: Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Block success rate
Success rate defined as motor block of the femoral nerve (knee extension) and the obturator nerve (hip adduction) and reduced sensory of the lateral femoral cutaneous nerve (middle of the lateral side of the thigh).
Measured: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Block success rate
Defined as above after lumbar plexus block with the Shamrock technique for motor response on electrical nerve stimulation above respectively below 0,5 milliampere (mA).
Measured: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Epidural spread of local anesthetics with contrast
Estimated with T1- and T2-weighted and with diffusion weighted imaging (DWI) MR scanning.
Measured: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Perineural spread of local anesthetics with added contrast
Estimated with T1- and T2-weighted and with DWI MR scanning.
Measured: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Depth of block needle
The depth in cm from the injection site in the skin to the needle tips position during injection. of local anesthetics
Measured: Estimated during block
Injection site
The distance in cm from the injection site of the block needle to the midline of the volunteer.
Measured: Estimated immediately after block placement
Minimal electrical nerve stimulation
The estimated minimal electrical nerve stimulation in mA to trigger a muscular response.
Measured: Estimated immediately before injection of local anesthetics during block placement
Type of response on electrical nerve stimulation
The type of response triggered by electrical nerve stimulation.
Measured: Assessed immediately before injection of local anesthetics during block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- AP Moeller Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas F Bendtsen, MD,PhD,Prof., Principal investigator, Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255591
- Sponsor's protocol ID
- AUH-TFB-SR
- Other IDs
- 2013-005346-10
- Status last verified
- Sep 2014
- First submitted
- 22 Sep 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Visme V, Picart F, Le Jouan R, Legrand A, Savry C, Morin V. Combined lumbar and sacral plexus block compared with plain bupivacaine spinal anesthesia for hip fractures in the elderly. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):158-62. doi: 10.1053/rapm.2000.0250158.
PubMed 10746528Kirchmair L, Entner T, Kapral S, Mitterschiffthaler G. Ultrasound guidance for the psoas compartment block: an imaging study. Anesth Analg. 2002 Mar;94(3):706-10; table of contents. doi: 10.1097/00000539-200203000-00042.
PubMed 11867402Kirchmair L, Entner T, Wissel J, Moriggl B, Kapral S, Mitterschiffthaler G. A study of the paravertebral anatomy for ultrasound-guided posterior lumbar plexus block. Anesth Analg. 2001 Aug;93(2):477-81, 4th contents page. doi: 10.1097/00000539-200108000-00047.
PubMed 11473883Morimoto M, Kim JT, Popovic J, Jain S, Bekker A. Ultrasound-guided lumbar plexus block for open reduction and internal fixation of hip fracture. Pain Pract. 2006 Jun;6(2):124-6. doi: 10.1111/j.1533-2500.2006.00074.x.
PubMed 17309721Doi K, Sakura S, Hara K. A modified posterior approach to lumbar plexus block using a transverse ultrasound image and an approach from the lateral border of the transducer. Anaesth Intensive Care. 2010 Jan;38(1):213-4. No abstract available.
PubMed 20191806Madison SJ, Ilfeld BM, Loland VJ, Mariano ER. Posterior lumbar plexus perineural catheter insertion by ultrasound guidance alone. Acta Anaesthesiol Scand. 2011 Sep;55(8):1031-2. doi: 10.1111/j.1399-6576.2011.02489.x. Epub 2011 Jul 20. No abstract available.
PubMed 21770905Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026.
PubMed 18344573Strid JMC, Sauter AR, Ullensvang K, Andersen MN, Daugaard M, Bendtsen MAF, Soballe K, Pedersen EM, Borglum J, Bendtsen TF. Ultrasound-guided lumbar plexus block in volunteers; a randomized controlled trial. Br J Anaesth. 2017 Mar 1;118(3):430-438. doi: 10.1093/bja/aew464.
PubMed 28203808
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02255591
- Acronym / sponsor ID
- AUH-TFB-SR
- Conditions
- Hip Fractures, Anesthesia Local, Pain, Postoperative
- Keywords
- Hip surgery anesthesia, Perioperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- AP Moeller Foundation
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Oct 2014 (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 main objective of the trial is to complete a double-blinded randomized controlled trial of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident technique by estimating the time of performance of lumbar plexus blocks in healthy volunteers.
Secondary objectives include a) estimates of number and depth of needle injections, distance of injection site from the midline, minimal electric nerve stimulation to trigger muscular response and the type of response, and volunteer discomfort during block injection, b) measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e) perineural and epidural distribution of local anesthetics added contrast visualized on magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy volunteers.
The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound technique, and that the success rate of the Shamrock technique is equal to or higher than the Lumbar Ultrasound Trident technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shamrock | Experimental | Drug: Lidocaine-adrenaline added gadolinium.Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium. |
| Lumbar Ultrasound Trident | Active comparator | Drug: Lidocaine-adrenaline added gadolinium.Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age ≥ 18 years
- Volunteers who have given their written and oral consent to participate in the study after fully understanding the content and the limitations of the protocol
- Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)
Key exclusion criteria (9 listed)
- Volunteers not able to cooperate for the study
- Volunteers not able to understand Danish
- Daily use of analgesics
- Allergy against the medicines used in the study
- Drug abuse (according to the investigator's judgement)
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 |
|---|---|---|
| Lidocaine-adrenaline added gadolinium. | Drug | Lumbar Ultrasound Trident, Shamrock |
Primary outcome
Block performance time
Time frame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.
15 secondary outcomes
Number of needle feeds
Time frame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Discomfort during block placement
Time frame: Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.
Plasma Lidocaine
Time frame: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Mear arterial pressure
Time frame: Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Cost-effectiveness
Time frame: Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.
Sensor block
Time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Motor block
Time frame: Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Block success rate
Time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Block success rate
Time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Epidural spread of local anesthetics with contrast
Time frame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Perineural spread of local anesthetics with added contrast
Time frame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Depth of block needle
Time frame: Estimated during block
Injection site
Time frame: Estimated immediately after block placement
Minimal electrical nerve stimulation
Time frame: Estimated immediately before injection of local anesthetics during block placement
Type of response on electrical nerve stimulation
Time frame: Assessed immediately before injection of local anesthetics during block placement
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 1 May 2015.
- Background: PubMed 10746528de Visme V, Picart F, Le Jouan R, Legrand A, Savry C, Morin V. Combined lumbar and sacral plexus block compared with plain bupivacaine spinal anesthesia for hip fractures in the elderly. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):158-62. doi: 10.1053/rapm.2000.0250158.
- Background: PubMed 11867402Kirchmair L, Entner T, Kapral S, Mitterschiffthaler G. Ultrasound guidance for the psoas compartment block: an imaging study. Anesth Analg. 2002 Mar;94(3):706-10; table of contents. doi: 10.1097/00000539-200203000-00042.
- Background: PubMed 11473883Kirchmair L, Entner T, Wissel J, Moriggl B, Kapral S, Mitterschiffthaler G. A study of the paravertebral anatomy for ultrasound-guided posterior lumbar plexus block. Anesth Analg. 2001 Aug;93(2):477-81, 4th contents page. doi: 10.1097/00000539-200108000-00047.
- Background: PubMed 17309721Morimoto M, Kim JT, Popovic J, Jain S, Bekker A. Ultrasound-guided lumbar plexus block for open reduction and internal fixation of hip fracture. Pain Pract. 2006 Jun;6(2):124-6. doi: 10.1111/j.1533-2500.2006.00074.x.
- Background: PubMed 20191806Doi K, Sakura S, Hara K. A modified posterior approach to lumbar plexus block using a transverse ultrasound image and an approach from the lateral border of the transducer. Anaesth Intensive Care. 2010 Jan;38(1):213-4. No abstract available.
- Background: PubMed 21770905Madison SJ, Ilfeld BM, Loland VJ, Mariano ER. Posterior lumbar plexus perineural catheter insertion by ultrasound guidance alone. Acta Anaesthesiol Scand. 2011 Sep;55(8):1031-2. doi: 10.1111/j.1399-6576.2011.02489.x. Epub 2011 Jul 20. No abstract available.
- Background: PubMed 18344573Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026.
- Derived from this study: PubMed 28203808Strid JMC, Sauter AR, Ullensvang K, Andersen MN, Daugaard M, Bendtsen MAF, Soballe K, Pedersen EM, Borglum J, Bendtsen TF. Ultrasound-guided lumbar plexus block in volunteers; a randomized controlled trial. Br J Anaesth. 2017 Mar 1;118(3):430-438. doi: 10.1093/bja/aew464.
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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 F Bendtsen, MD,PhD,Prof. principal investigator
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine-adrenaline added gadolinium. in people with Hip Fractures and Anesthesia Local, run by University of Aarhus at 1 site in Denmark.
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 9 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 1 May 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Block performance time (time frame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.). 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 NCT02255591, which also lists 8 linked publications.
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 1 May 2015.