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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia, Local; Hip Fractures
• Intervention / Treatment: Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock); Drug: Lidocaine-epinephrine added gadoterate meglumine; Procedure: Ultrasound guided lumbar plexus block (Shamrock)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shamrock guided by US/MR image fusion; Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).	Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock); Drug: Lidocaine-epinephrine added gadoterate meglumine; 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.
Other: Shamrock guided by US; Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).	Drug: Lidocaine-epinephrine added gadoterate meglumine; 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.; Procedure: Ultrasound guided lumbar plexus block (Shamrock)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.
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).	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
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.	Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)	Type of neuromuscular response on electrical nerve stimulation.	Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
Needle advancements	Number of needle advancements during intervention.	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Injection site		Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Block needle depth		Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Discomfort	Estimated on numeric rating scale 0-10	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Mean arterial pressure change		Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.
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		Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.		Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
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.	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.
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.	Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.
Cost-effectiveness (ICER)	ICER is estimated as the difference in mean marginal cost of the blocks.	Calculated 1 month after study completion. Data will be presented 10 months after study completion.
Quantitative diffusion weighted MRI reproducibility		Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
Image evaluation of diffusion weighted MRI reproducibility		Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; AP Moeller Foundation; Bendtsen, Thomas Fichtner, M.D, Ph.D.
• Investigators: Principal Investigator: Jennie MC Strid, M.D., Department of Anesthesiology and Intensive Care, Aarhus University Offical

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Hip surgery anesthesia; Perioperative analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Hip Fractures; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Chelating Agents; Sequestering Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
• Other Study ID Numbers: AUH-TFB-SR-ULMR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No