Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AP Moeller Foundation | OTHER |
| Aarhus University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprasacral Parallel Shift guided by US/MR image fusion | Experimental | 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). |
|
| Suprasacral Parallel Shift guided by US | Active Comparator | Use of ultrasound guided Suprasacral Parallel Shift technique to place a lumbar plexus block (20 mL 2% lidocaine with epinephrine added gadoterate meglumine). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine-epinephrine added gadoterate meglumine | Drug |
|
| 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). |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care, Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28396863 | Derived | Strid JM, Pedersen EM, Al-Karradi SN, Bendtsen MA, Bjorn S, Dam M, Daugaard M, Hansen MS, Linnet KD, Borglum J, Soballe K, Bendtsen TF. Real-Time Ultrasound/MRI Fusion for Suprasacral Parallel Shift Approach to Lumbosacral Plexus Blockade and Analysis of Injectate Spread: An Exploratory Randomized Controlled Trial. Biomed Res Int. 2017;2017:1873209. doi: 10.1155/2017/1873209. Epub 2017 Mar 15. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D007869 |
| Leg Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |