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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Anesthesia Local; Pain, Perioperative
• Intervention / Treatment: Drug: Lidocaine-epinephrine added gadoterate meglumine

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C, Denmark, 8000
    • Department of Anesthesiology and Intensive Care, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suprasacral Parallel Shift guided by US/MR image fusion; 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
Active Comparator: Suprasacral Parallel Shift guided by US; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thomas F. Bendtsen
• Collaborators: Aarhus University Hospital; AP Moeller Foundation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Hip surgery anesthesia; Perioperative analgesia
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; 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-SSPS