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Completed

NCT Number: NCT02718976

Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

The main objective is to complete a double-blinded randomized controlled crossover trial of lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy volunteers.

The investigators will assess block procedure-related parameters, anatomical spread of local anesthetic, and motor and sensory effects.

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Body mass index (BMI): 18.5 ≤ BMI ≤30
  • Written and oral consent to participate
  • Normal healthy person (American Society of Anesthesiology Classification I)

Exclusion criteria

  • Volunteers not abel to speak or understand Danish
  • Volunteers not able to cooperate
  • Allergy against the medicines used in the study
  • Daily use of analgesics
  • Drug abuse - according to the investigator's judgment
  • Alcohol consumption greater than the recommendations of the Danish National Board of Health
  • Contraindication for MRI scan (including pregnancy)
  • Volunteers in whom nerve blocks are impossible due to technical reasons or infection
  • Volunteers who are incompetent, eg. surrogate consent is unaccepted

Treatment and study plan

Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)

Procedure

Ultrasound guided lumbar plexus block (Shamrock)

Procedure

Lidocaine-epinephrine added gadoterate meglumine

Drug

Perineural injection of 20 ml 2% lidocaine with 0.0005% epinephrine added 1 ml of gadoterate meglumine (0.13 ml) and sodium chloride (NaCl, 0.87 ml). The 1 ml of gadoterate meglumine-NaCl is added to the local anesthetic prior to the perineural injection in order to enhance visualization of the local anesthetic on MRI scanning after the intervention.

Primary outcomes

  1. Number of participants with a successful block of the femoral and obturator nerves (reduced muscle force compared to baseline assessed with handheld dynamometer), and of the lateral femoral cutaneous nerve (assessed with cold and pinprick test)

    Time frame: Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.

    Block success is defined as the number of volunteers with a successful motor block of the femoral nerve and the obturator nerve, and with a successful sensory block of the lateral femoral cutaneous nerve. Motor block is a proxy marker of sensory block. A participant with a successful motor block has reduced muscle force after block compared to baseline muscle force assessed with handheld dynamometer, and a participant with a successful sensory block has decreased/absent sensation for cold and/or pinprick.

Secondary outcomes

  1. Time for preparation of block procedure (seconds)

    Time frame: Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.

    Time for block preparation is defined as the time period from the time point when the volunteer is placed on the block bed to the time point when the pre-ultrasound scanning before intervention is complete.

  2. Time for block procedure (seconds)

    Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

    Time for block procedure is defined as the time period from the time point when the ultrasound probe is placed on the skin after completed preparation to the time point when the block needle is pulled out after injection of local anesthetics (end of intervention).

  3. Electrical nerve stimulation strength (mA)

    Time frame: Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.

    Minimal electrical nerve stimulation (mA) required to trigger neuromuscular response and confirm correct placement of block needle prior to injection of local anesthetics.

  4. Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)

    Time frame: Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.

    Type of neuromuscular response on electrical nerve stimulation.

  5. Needle advancements

    Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

    Number of needle advancements during intervention.

  6. Injection site

    Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

  7. Block needle depth

    Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

  8. Discomfort

    Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

    Estimated on numeric rating scale 0-10

  9. Mean arterial pressure change

    Time frame: Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.

  10. Number of participants with visual confirmed contact between the injectate and the spinal nerves L2-S1, the femoral, the obturator, and the lateral femoral cutaneous nerves, and the lumbosacral trunk assessed on MRI

    Time frame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.

  11. Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.

    Time frame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.

  12. Number of participants with motor block

    Time frame: Baseline muscle strength is estimated prior to first intervention. Post-block muscle strength is estimated 60 minutes after intervention. Data will be presented 10 months after study completion.

    Muscle strength of the femoral, obturator, superior gluteal, and sciatic nerves are estimated with handheld dynamometer during knee extension, hip adduction, hip abduction, and knee flexion. Motor block is assessed as reduced muscle strength compared to baseline.

  13. Number of participants with sensory block

    Time frame: Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.

    Sensory block is defined as decreased or absent sensation for cold, warmth, touch, and pinprick are assessed for the dermatomes T8-S3 and the lateral femoral cutaneous nerve.

  14. Cost-effectiveness (ICER)

    Time frame: Calculated 1 month after study completion. Data will be presented 10 months after study completion.

    ICER is estimated as the difference in mean marginal cost of the blocks.

  15. Quantitative diffusion weighted MRI reproducibility

    Time frame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.

  16. Image evaluation of diffusion weighted MRI reproducibility

    Time frame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • AP Moeller Foundation
  • Aarhus University Hospital
  • Bendtsen, Thomas Fichtner, M.D, Ph.D.

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2016
Registry last updated
Apr 26, 2016

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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