Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus
NCT ID: NCT02255591
Last Updated: 2015-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2015-02-28
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Shamrock
Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.
Lidocaine-adrenaline added gadolinium.
Lumbar Ultrasound Trident
Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.
Lidocaine-adrenaline added gadolinium.
Interventions
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Lidocaine-adrenaline added gadolinium.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
18 Years
65 Years
MALE
Yes
Sponsors
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AP Moeller Foundation
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Thomas F Bendtsen, MD,PhD,Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark
Locations
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Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital
Aarhus C, , Denmark
Countries
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References
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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.
Kirchmair 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.
Kirchmair 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.
Morimoto 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.
Doi 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.
Madison 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.
Karmakar 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.
Strid 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.
Other Identifiers
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2013-005346-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AUH-TFB-SR
Identifier Type: -
Identifier Source: org_study_id
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