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

Phase 4

Completed

• Conditions: Hip Fractures; Pain, Postoperative; Anesthesia Local
• Interventions: Drug: Lidocaine-adrenaline added gadolinium.

• Registration Number: NCT02255591
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-22
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-02
• Study Start: 2015-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Shamrock	Lidocaine-adrenaline added gadolinium.	Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.
Lumbar Ultrasound Trident	Lidocaine-adrenaline added gadolinium.	Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.

Primary Outcome Measures

Name	Time	Method
Block performance time	Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	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.

Secondary Outcome Measures

Name	Time	Method
Number of needle feeds	Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	Needle feeds are defined as retraction of needle followed by new feed of the needle disregarding the number of skin punctures.
Cost-effectiveness	Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.	Cost-effectiveness estimated as extra expense per successful lumbar plexus block and calculated as incremental cost-effectiveness ratio (ICER).
Minimal electrical nerve stimulation	Estimated immediately before injection of local anesthetics during block placement	The estimated minimal electrical nerve stimulation in mA to trigger a muscular response.
Sensor block	Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	Sensor block (cold, warm, touch, and pain) of the dermatomes T8-S3 and of the femoral nerve and the lateral femoral cutaneous nerve.
Epidural spread of local anesthetics with contrast	Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	Estimated with T1- and T2-weighted and with diffusion weighted imaging (DWI) MR scanning.
Type of response on electrical nerve stimulation	Assessed immediately before injection of local anesthetics during block placement	The type of response triggered by electrical nerve stimulation.
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.
Perineural spread of local anesthetics with added contrast	Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	Estimated with T1- and T2-weighted and with DWI MR scanning.
Depth of block needle	Estimated during block	The depth in cm from the injection site in the skin to the needle tips position during injection. of local anesthetics
Injection site	Estimated immediately after block placement	The distance in cm from the injection site of the block needle to the midline of the volunteer.
Discomfort during block placement	Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.	Discomfort is measured with Numeric Rating Scale (NRS).
Mear arterial pressure	Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
Motor block	Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	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).
Block success rate	Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.	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).

Trial Locations

Locations (1)

Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark