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Completed

NCT Number: NCT02255591

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

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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Key information

Conditions

Hip Fractures Anesthesia Local Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital

Aarhus C, DK-8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine-adrenaline added gadolinium.

Drug

Primary outcomes

  1. Block performance time

    Time frame: 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 outcomes

  1. Number of needle feeds

    Time frame: 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.

  2. Discomfort during block placement

    Time frame: 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).

  3. Plasma Lidocaine

    Time frame: 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.

  4. Mear arterial pressure

    Time frame: Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

  5. Cost-effectiveness

    Time frame: 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).

  6. Sensor block

    Time frame: 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.

  7. Motor block

    Time frame: 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).

  8. Block success rate

    Time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.

    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).

  9. Block success rate

    Time frame: 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).

  10. Epidural spread of local anesthetics with contrast

    Time frame: 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.

  11. Perineural spread of local anesthetics with added contrast

    Time frame: 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.

  12. Depth of block needle

    Time frame: Estimated during block

    The depth in cm from the injection site in the skin to the needle tips position during injection. of local anesthetics

  13. Injection site

    Time frame: Estimated immediately after block placement

    The distance in cm from the injection site of the block needle to the midline of the volunteer.

  14. Minimal electrical nerve stimulation

    Time frame: Estimated immediately before injection of local anesthetics during block placement

    The estimated minimal electrical nerve stimulation in mA to trigger a muscular response.

  15. Type of response on electrical nerve stimulation

    Time frame: Assessed immediately before injection of local anesthetics during block placement

    The type of response triggered by electrical nerve stimulation.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • AP Moeller Foundation

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2014
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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