Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Hip Fractures; Anesthesia, Local; Pain, Postoperative

Treatments: Drug: Lidocaine-epinephrine added gadoterate meglumine; Procedure: Ultrasound guided lumbar plexus block (Shamrock); Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)

Study type: Interventional

Funder types: Other

Identifiers

NCT02718976

AUH-TFB-SR-ULMR

Details and patient eligibility

About

The main objective is to complete a double-blinded randomized controlled crossover trial of lumbar plexus block with the Shamrock technique guided by ultrasound (US)/magnetic resonance imaging (MRI) image fusion vs. the Shamrock technique guided by ultrasound in healthy volunteers.

The investigators will assess block procedure-related parameters, anatomical spread of local anesthetic, and motor and sensory effects.

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age ≥ 18 years
• Body mass index (BMI): 18.5 ≤ BMI ≤30
• Written and oral consent to participate
• Normal healthy person (American Society of Anesthesiology Classification I)

Exclusion Criteria:

• Volunteers not abel to speak or understand Danish
• Volunteers not able to cooperate
• Allergy against the medicines used in the study
• Daily use of analgesics
• Drug abuse - according to the investigator's judgment
• Alcohol consumption greater than the recommendations of the Danish National Board of Health
• Contraindication for MRI scan (including pregnancy)
• Volunteers in whom nerve blocks are impossible due to technical reasons or infection
• Volunteers who are incompetent, eg. surrogate consent is unaccepted

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Shamrock guided by US/MR image fusion

Experimental group

Description:

Use of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).

Treatment:

Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)

Drug: Lidocaine-epinephrine added gadoterate meglumine

Shamrock guided by US

Other group

Description:

Use of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).

Treatment:

Drug: Lidocaine-epinephrine added gadoterate meglumine

Procedure: Ultrasound guided lumbar plexus block (Shamrock)