Clinical trial NCT02593370: Suprasacral Parallel Shift - Ultrasound/MR Image Fusion Guided Lumbosacral Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hip Fractures
Anesthesia Local
Pain, Perioperative
Keywords: Hip surgery anesthesia
Perioperative analgesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: AP Moeller Foundation
name: Aarhus University Hospital
First posted: 2015-11-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Block success
timeFrame: Estimated 40 min after completed intervention. Presented 10 months after last patient last visit (LVLP).
Secondary outcomes:
measure: Plasma lidocaine
timeFrame: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after intervention. Presented 10 months after LVLP
measure: Time for preparation
timeFrame: Estimated prior to intervention. Presented 10 months after LVLP
measure: Block procedure time
timeFrame: Estimated during intervention. Presented 10 months after LVLP
measure: Injection site
timeFrame: Estimated at the end of the intervention. Presented 10 months after LVLP
measure: Block needle depth
timeFrame: Estimated at the end of the intervention. Presented 10 months after LVLP
measure: Discomfort
timeFrame: Estimated immediately after the intervention. Presented 10 months after LVLP
measure: Mean arterial pressure change
timeFrame: Mean arterial pressure is measured prior intervention and 5 min after intervention. Presented 10 months after LVLP
measure: Sensory (cold, warm, touch, pain) block of the dermatomes T12-S3 and the lateral femoral cutaneous nerve
timeFrame: Estimated 50 min after intervention. Presented 10 months after LVLP
measure: Perineural spread of local anesthetics added gadoterate meglumine
timeFrame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
measure: Epidural spread of local anesthetics added gadoterate meglumine
timeFrame: Estimated on MRI sampled 10-30 minutes after intervention. Presented 10 months after LVLP
measure: Cost-effectiveness (ICER)
timeFrame: Calculated after LVLP. Presented 10 months after the last visit of the last volunteer
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Anesthesiology and Intensive Care, Aarhus University Hospital
Study officials:
References:
citation: 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.