Clinical trial NCT02255591: Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus
Official title: Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fractures
Anesthesia Local
Pain, Postoperative
Keywords: Hip surgery anesthesia
Perioperative analgesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: AP Moeller Foundation
First posted: 2014-10-02
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Block performance time
timeFrame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Secondary outcomes:
measure: Number of needle feeds
timeFrame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Discomfort during block placement
timeFrame: Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Plasma Lidocaine
timeFrame: 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.
measure: Mear arterial pressure
timeFrame: Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Cost-effectiveness
timeFrame: Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.
measure: Sensor block
timeFrame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Motor block
timeFrame: Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Block success rate
timeFrame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Block success rate
timeFrame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Epidural spread of local anesthetics with contrast
timeFrame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Perineural spread of local anesthetics with added contrast
timeFrame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Depth of block needle
timeFrame: Estimated during block
measure: Injection site
timeFrame: Estimated immediately after block placement
measure: Minimal electrical nerve stimulation
timeFrame: Estimated immediately before injection of local anesthetics during block placement
measure: Type of response on electrical nerve stimulation
timeFrame: Assessed immediately before injection of local anesthetics during block placement
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark
name: Thomas F Bendtsen, MD,PhD,Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.