Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; AP Moeller Foundation; Bendtsen, Thomas Fichtner, M.D, Ph.D.
• Treatments: Epinephrine; Epinephryl borate; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Lidocaine; Racepinephrine

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