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Completed

NCT Number: NCT02593370

Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a lumbosacral plexus block with the Suprasacral Parallel Shift technique guided by ultrasound/magnetic resonance (MR) image fusion vs. Suprasacral Parallel Shift guided by ultrasound by estimating sensory block of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 in healthy volunteers.

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Key information

Conditions

Hip Fractures Anesthesia Local Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Neurologic Manifestations Pain Pain, Perioperative Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Anesthesiology and Intensive Care, Aarhus University Hospital

Aarhus C, 8000, Denmark

About this study

The main objective of the trial is to complete a double-blinded randomized controlled trial with crossover design of a one-injection nerve block of the lower part of the lumbar plexus and the upper part of the sacral plexus (Suprasacral Parallel Shift, SSPS) to achieve analgesia of the femoral nerve, the obturator nerve, the lumbosacral trunk, and spinal nerve L1 with SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound by estimating sensory block of in healthy volunteers by estimating the sensory block of dermatomes of the terminal nerves in healthy volunteers.

The secondary objective is to estimate a) preparation and b) procedure time, c) injection site and d) depth, e) discomfort, f) change in MAP, g) plasma lidocaine pharmacokinetics, h) motor and i) sensory block, j) perineural and k) epidural spread of lidocaine-epinephrine added gadotorate meglumine on MRI, and l) cost-effectiveness of SSPS guided by ultrasound/MR image fusion vs. SSPS guided by ultrasound.

The investigators hypothesize that block success is higher for SSPS guided by ultrasound/MR image fusion than for SSPS guided by ultrasound.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Volunteers who has given their written and oral informed consent to participate in the study after having fully understood the content and the limitations of the protocol.
  • Normal healthy person (American Society of Anesthesiology [ASA] Classification I)

Exclusion criteria

  • Volunteers not able to cooperate in the study
  • Volunteers not able to understand or speak Danish
  • Daily use of analgesics
  • Allergy against the medicines used in the study
  • Drug abuse (according to the investigator's judgement)
  • Alcohol consumption greater than the recommendations of the Danish National Board of Health
  • Contraindication for MRI including pregnancy
  • Volunteer in whom nerve blocks are not possible due to technical reasons
  • Volunteer who are incompetent (ie. surrogate consent is not accepted)

Treatment and study plan

Lidocaine-epinephrine added gadoterate meglumine

Drug

Primary outcomes

  1. Block success

    Time frame: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).

    Block success of the clinical relevant lumbosacral nerves that innervate the hip joint capsule estimated as significant motor block of the obturator nerve, the femoral nerve, and the lumbosacral trunk. Motor block is a significant proxy marker of sensory block. Motor block (muscle strength, mmHg) is assessed with a handheld dynamometer.

Secondary outcomes

  1. Plasma lidocaine

    Time frame: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP

  2. Time for preparation

    Time frame: Estimated prior to intervention. Presented 10 months after LVLP

    Time for preparation in seconds is defined as the time of placement of the volunteer on the bed until the end of pre-ultrasound scanning

  3. Block procedure time

    Time frame: Estimated during intervention. Presented 10 months after LVLP

    Block procedure time in seconds is defined as the time of the placement of the ultrasound probe on the skin to until the block needle is pulled out after injection of local anesthetics

  4. Injection site

    Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP

  5. Block needle depth

    Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP

  6. Discomfort

    Time frame: Estimated immediately after the intervention. Presented 10 months after LVLP

    Estimated on numeric rating scale 0-10

  7. Mean arterial pressure change

    Time frame: Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP

  8. Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve

    Time frame: Estimated 50 min after intervention. Presented 10 months after LVLP

  9. Perineural spread of local anesthetics added gadoterate meglumine

    Time frame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP

  10. Epidural spread of local anesthetics added gadoterate meglumine

    Time frame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP

  11. Cost-effectiveness (ICER)

    Time frame: Calculated after LVLP. Presented 10 months after the last visit of the last volunteer

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

Sponsors and collaborators

Lead sponsor

Thomas F. Bendtsen

Other

Collaborators

  • AP Moeller Foundation
  • Aarhus University Hospital

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 2, 2015
Registry last updated
Feb 12, 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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