Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

Pain, Postoperative Clinical Trial

Official title:

Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718976
• Other study ID #: AUH-TFB-SR-ULMR
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2016
• Last updated: April 24, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: February 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Local
• Hip Fractures
• Pain, Postoperative

Intervention

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

• Ultrasound guided lumbar plexus block (Shamrock)

Drug:
• Lidocaine-epinephrine added gadoterate meglumine
Perineural injection of 20 ml 2% lidocaine with 0.0005% epinephrine added 1 ml of gadoterate meglumine (0.13 ml) and sodium chloride (NaCl, 0.87 ml). The 1 ml of gadoterate meglumine-NaCl is added to the local anesthetic prior to the perineural injection in order to enhance visualization of the local anesthetic on MRI scanning after the intervention.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, AP Moeller Foundation, Bendtsen, Thomas Fichtner, M.D, Ph.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a successful block of the femoral and obturator nerves (reduced muscle force compared to baseline assessed with handheld dynamometer), and of the lateral femoral cutaneous nerve (assessed with cold and pinprick test)	Block success is defined as the number of volunteers with a successful motor block of the femoral nerve and the obturator nerve, and with a successful sensory block of the lateral femoral cutaneous nerve. Motor block is a proxy marker of sensory block. A participant with a successful motor block has reduced muscle force after block compared to baseline muscle force assessed with handheld dynamometer, and a participant with a successful sensory block has decreased/absent sensation for cold and/or pinprick.	Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Time for preparation of block procedure (seconds)	Time for block preparation is defined as the time period from the time point when the volunteer is placed on the block bed to the time point when the pre-ultrasound scanning before intervention is complete.	Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.	No
Secondary	Time for block procedure (seconds)	Time for block procedure is defined as the time period from the time point when the ultrasound probe is placed on the skin after completed preparation to the time point when the block needle is pulled out after injection of local anesthetics (end of intervention).	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.	No
Secondary	Electrical nerve stimulation strength (mA)	Minimal electrical nerve stimulation (mA) required to trigger neuromuscular response and confirm correct placement of block needle prior to injection of local anesthetics.	Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.	Yes
Secondary	Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)	Type of neuromuscular response on electrical nerve stimulation.	Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.	Yes
Secondary	Needle advancements	Number of needle advancements during intervention.	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Injection site		Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Block needle depth		Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Discomfort	Estimated on numeric rating scale 0-10	Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.	No
Secondary	Mean arterial pressure change		Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Number of participants with visual confirmed contact between the injectate and the spinal nerves L2-S1, the femoral, the obturator, and the lateral femoral cutaneous nerves, and the lumbosacral trunk assessed on MRI		Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.		Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Number of participants with motor block	Muscle strength of the femoral, obturator, superior gluteal, and sciatic nerves are estimated with handheld dynamometer during knee extension, hip adduction, hip abduction, and knee flexion. Motor block is assessed as reduced muscle strength compared to baseline.	Baseline muscle strength is estimated prior to first intervention. Post-block muscle strength is estimated 60 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Number of participants with sensory block	Sensory block is defined as decreased or absent sensation for cold, warmth, touch, and pinprick are assessed for the dermatomes T8-S3 and the lateral femoral cutaneous nerve.	Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.	Yes
Secondary	Cost-effectiveness (ICER)	ICER is estimated as the difference in mean marginal cost of the blocks.	Calculated 1 month after study completion. Data will be presented 10 months after study completion.	No
Secondary	Quantitative diffusion weighted MRI reproducibility		Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.	No
Secondary	Image evaluation of diffusion weighted MRI reproducibility		Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.	No