Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Hip Fractures; Anesthesia Local
• Intervention / Treatment: Drug: Lidocaine-adrenaline added gadolinium.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, DK-8000
    • Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shamrock; Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.	Drug: Lidocaine-adrenaline added gadolinium.
Active Comparator: 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.	Drug: Lidocaine-adrenaline added gadolinium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: AP Moeller Foundation
• Investigators: Principal Investigator: Thomas F Bendtsen, MD,PhD,Prof., Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 22, 2014
• First Submitted That Met QC Criteria: September 29, 2014
• First Posted (Estimate): October 2, 2014

Study Record Updates

• Last Update Posted (Estimate): May 1, 2015
• Last Update Submitted That Met QC Criteria: April 30, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Hip surgery anesthesia; Perioperative analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Hip Fractures; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: AUH-TFB-SR; 2013-005346-10 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No