Back to resultsShamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Primary Purpose
Hip Fractures, Anesthesia, Local, Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)
Ultrasound guided lumbar plexus block (Shamrock)
Lidocaine-epinephrine added gadoterate meglumine
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip surgery anesthesia, Perioperative analgesia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Shamrock guided by US/MR image fusion
Shamrock guided by US
Arm Description
Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Outcomes
Primary Outcome Measures
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)
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 Outcome Measures
Time for preparation of block procedure (seconds)
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.
Time for block procedure (seconds)
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).
Electrical nerve stimulation strength (mA)
Minimal electrical nerve stimulation (mA) required to trigger neuromuscular response and confirm correct placement of block needle prior to injection of local anesthetics.
Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)
Type of neuromuscular response on electrical nerve stimulation.
Needle advancements
Number of needle advancements during intervention.
Injection site
Block needle depth
Discomfort
Estimated on numeric rating scale 0-10
Mean arterial pressure change
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
Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.
Number of participants with motor block
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.
Number of participants with sensory block
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.
Cost-effectiveness (ICER)
ICER is estimated as the difference in mean marginal cost of the blocks.
Quantitative diffusion weighted MRI reproducibility
Image evaluation of diffusion weighted MRI reproducibility
Full Information
NCT ID
NCT02718976
First Posted
February 22, 2016
Last Updated
April 24, 2016
Sponsor
University of Aarhus
Collaborators
Bendtsen, Thomas Fichtner, M.D, Ph.D., AP Moeller Foundation, Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02718976
Brief Title
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Official Title
Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Bendtsen, Thomas Fichtner, M.D, Ph.D., AP Moeller Foundation, Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Anesthesia, Local, Pain, Postoperative
Keywords
Hip surgery anesthesia, Perioperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shamrock guided by US/MR image fusion
Arm Type
Experimental
Arm Description
Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Arm Title
Shamrock guided by US
Arm Type
Other
Arm Description
Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Intervention Type
Procedure
Intervention Name(s)
Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided lumbar plexus block (Shamrock)
Intervention Type
Drug
Intervention Name(s)
Lidocaine-epinephrine added gadoterate meglumine
Intervention Description
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 Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.
Secondary Outcome Measure Information:
Title
Time for preparation of block procedure (seconds)
Description
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.
Time Frame
Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.
Title
Time for block procedure (seconds)
Description
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).
Time Frame
Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Title
Electrical nerve stimulation strength (mA)
Description
Minimal electrical nerve stimulation (mA) required to trigger neuromuscular response and confirm correct placement of block needle prior to injection of local anesthetics.
Time Frame
Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
Title
Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)
Description
Type of neuromuscular response on electrical nerve stimulation.
Time Frame
Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
Title
Needle advancements
Description
Number of needle advancements during intervention.
Time Frame
Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Title
Injection site
Time Frame
Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Title
Block needle depth
Time Frame
Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Title
Discomfort
Description
Estimated on numeric rating scale 0-10
Time Frame
Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Title
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.
Title
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.
Title
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.
Title
Number of participants with motor block
Description
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.
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.
Title
Number of participants with sensory block
Description
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.
Time Frame
Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.
Title
Cost-effectiveness (ICER)
Description
ICER is estimated as the difference in mean marginal cost of the blocks.
Time Frame
Calculated 1 month after study completion. Data will be presented 10 months after study completion.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie MC Strid, M.D.
Organizational Affiliation
Department of Anesthesiology and Intensive Care, Aarhus University Offical
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
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