Clinical trial NCT02718976: Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Official title: Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hip Fractures
Anesthesia, Local
Pain, Postoperative
Keywords: Hip surgery anesthesia
Perioperative analgesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Bendtsen, Thomas Fichtner, M.D, Ph.D.
name: AP Moeller Foundation
name: Aarhus University Hospital
First posted: 2016-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.
Secondary outcomes:
measure: Time for preparation of block procedure (seconds)
timeFrame: Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.
measure: Time for block procedure (seconds)
timeFrame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
measure: Electrical nerve stimulation strength (mA)
timeFrame: Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
measure: Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)
timeFrame: Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
measure: Needle advancements
timeFrame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
measure: Injection site
timeFrame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
measure: Block needle depth
timeFrame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
measure: Discomfort
timeFrame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
measure: Mean arterial pressure change
timeFrame: Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.
measure: 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
timeFrame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
measure: Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.
timeFrame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
measure: Number of participants with motor block
timeFrame: 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.
measure: Number of participants with sensory block
timeFrame: Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.
measure: Cost-effectiveness (ICER)
timeFrame: Calculated 1 month after study completion. Data will be presented 10 months after study completion.
measure: Quantitative diffusion weighted MRI reproducibility
timeFrame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
measure: Image evaluation of diffusion weighted MRI reproducibility
timeFrame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Aarhus University Offical
name: Jennie MC Strid, M.D.
role: PRINCIPAL_INVESTIGATOR
References: