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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Hip Fractures, Anesthesia Local, Pain, Perioperative

Intervention / Treatment
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* Drug: Lidocaine-epinephrine added gadoterate meglumine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprasacral Parallel Shift guided by US/MR image fusion<br>Use of ultrasound/MR image fusion guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). | Drug: Lidocaine-epinephrine added gadoterate meglumine<br> <br> |
| Active Comparator: Suprasacral Parallel Shift guided by US<br>Use of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). | Drug: Lidocaine-epinephrine added gadoterate meglumine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block success | 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. | Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lidocaine |  | Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP | 
| Time for preparation | 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 | Estimated prior to intervention. Presented 10 months after LVLP | 
| Block procedure time | 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 | Estimated during intervention. Presented 10 months after LVLP | 
| Injection site |  | Estimated at the end of the intervention. Presented 10 months after LVLP | 
| Block needle depth |  | Estimated at the end of the intervention. Presented 10 months after LVLP | 
| Discomfort | Estimated on numeric rating scale 0-10 | Estimated immediately after the intervention. Presented 10 months after LVLP | 
| Mean arterial pressure change |  | Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP | 
| Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve |  | Estimated 50 min after intervention. Presented 10 months after LVLP | 
| Perineural spread of local anesthetics added gadoterate meglumine |  | Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP | 
| Epidural spread of local anesthetics added gadoterate meglumine |  | Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP | 
| Cost-effectiveness (ICER) | ICER is estimated as the difference in mean marginal cost of the blocks. | Calculated after LVLP. Presented 10 months after the last visit of the last volunteer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip surgery anesthesia, Perioperative analgesia