Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

NCT02718976 | Completed Phase 2 DMC

• 1 other identifier: AUH-TFB-SR-ULMR
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hip Fractures; Anesthesia, Local; Pain, Postoperative

Keywords

Hip surgery anesthesia; Perioperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (16)

• Time for preparation of block procedure (seconds)

  Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.

• Time for block procedure (seconds)

  Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

• Electrical nerve stimulation strength (mA)

  Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.

• Electrical nerve stimulation response (quadriceps, sartorius, other muscular, paresthesia, none)

  Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.

• Needle advancements

  Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.

Study Arms (2)

Shamrock guided by US/MR image fusion

EXPERIMENTAL

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

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

Shamrock guided by US

OTHER

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

Procedure: Ultrasound guided lumbar plexus block (Shamrock); Drug: Lidocaine-epinephrine added gadoterate meglumine

Interventions

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

Shamrock guided by US/MR image fusion

Ultrasound guided lumbar plexus block (Shamrock) PROCEDURE

Shamrock guided by US

Lidocaine-epinephrine added gadoterate meglumine DRUG

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.

Shamrock guided by US; Shamrock guided by US/MR image fusion

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Bendtsen, Thomas Fichtner, M.D, Ph.D.: collaborator
• AP Moeller Foundation: collaborator
• Aarhus University Hospital: collaborator

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jennie MC Strid, M.D.

  Department of Anesthesiology and Intensive Care, Aarhus University Offical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share