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

Pain, Postoperative Clinical Trial

Official title:

Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255591
• Other study ID #: AUH-TFB-SR
• Secondary ID: 2013-005346-10
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2014
• Last updated: April 30, 2015
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia Local
• Hip Fractures
• Pain, Postoperative

Intervention

Drug:
• Lidocaine-adrenaline added gadolinium.

Locations

Country	Name	City	State
Denmark	Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	AP Moeller Foundation

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes
Secondary	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.	No
Secondary	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.	Yes
Secondary	Mear arterial pressure		Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	Yes
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes