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

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ClinicalTrials.gov Identifier: NCT02255591
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
AP Moeller Foundation
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hip Fractures Anesthesia Local Pain, Postoperative Drug: Lidocaine-adrenaline added gadolinium. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial
Study Start Date : February 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255591


Locations
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Denmark
Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital
Aarhus C, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
AP Moeller Foundation
Investigators
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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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02255591    
Other Study ID Numbers: AUH-TFB-SR
2013-005346-10 ( EudraCT Number )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: September 2014
Keywords provided by University of Aarhus:
Hip surgery anesthesia
Perioperative analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents