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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005346-10 | EudraCT Number |
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| Name | Class |
|---|---|
| AP Moeller Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shamrock | Experimental | Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine-adrenaline added gadolinium. | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer. |
| Discomfort during block placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas F Bendtsen, MD,PhD,Prof. | Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital | Aarhus C | DK-8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10746528 | Background | 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. | |
| 11867402 | Background | 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. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Discomfort is measured with Numeric Rating Scale (NRS). |
| Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer. |
| Plasma Lidocaine | 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 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). | 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. | 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). | 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). | 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). | 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. | 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. | 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 | Estimated during block |
| Injection site | The distance in cm from the injection site of the block needle to the midline of the volunteer. | Estimated immediately after block placement |
| Minimal electrical nerve stimulation | The estimated minimal electrical nerve stimulation in mA to trigger a muscular response. | 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. | Assessed immediately before injection of local anesthetics during block placement |
| 11473883 | Background | 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. |
| 17309721 | Background | 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. |
| 20191806 | Background | 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. |
| 21770905 | Background | 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. |
| 18344573 | Background | 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. |
| 28203808 | Derived | 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. |
| D007869 |
| Leg Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |