A Phase 1 interventional study of Lidocaine-epinephrine added gadoterate meglumine in Hip Fractures, Anesthesia Local and Pain, Perioperative, sponsored by Thomas F. Bendtsen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-12.
Sponsored by Thomas F. Bendtsen · Phase 1, Interventional, and Treatment
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.
848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's enrollment of 26 is below the median of 90 across 540 interventional studies indexed under Hip Fractures.
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Exclusion Criteria:
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
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
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.
Time frame: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).
Plasma lidocaine
Time frame: 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
Time frame: 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
Time frame: Estimated during intervention. Presented 10 months after LVLP
Injection site
Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP
Block needle depth
Time frame: Estimated at the end of the intervention. Presented 10 months after LVLP
Discomfort
Estimated on numeric rating scale 0-10
Time frame: Estimated immediately after the intervention. Presented 10 months after LVLP
Mean arterial pressure change
Time frame: 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
Time frame: Estimated 50 min after intervention. Presented 10 months after LVLP
Perineural spread of local anesthetics added gadoterate meglumine
Time frame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
Epidural spread of local anesthetics added gadoterate meglumine
Time frame: 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.
Time frame: Calculated after LVLP. Presented 10 months after the last visit of the last volunteer
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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