Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus

NCT02255591

Hip Fractures Anesthesia Local Pain, Postoperative

COMPLETED PHASE4

Ultrasound-assisted Shamrock Method for Lumbar Plexus Nerve Block in Elderly Trauma Patients, Revisited.

NCT04346758

Postoperative Pain

COMPLETED NA

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

NCT02593370

Hip Fractures Anesthesia Local Pain, Perioperative

COMPLETED PHASE1

Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

NCT06088368

Femoral Neck Fractures Lumbosacral Plexus Nerve Block

UNKNOWN NA

Continous Lumbar Plexus Block in Children

NCT03450096

Regional Anesthesia Pediatric Anesthesia Pain, Postoperative

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures Anesthesia, Local Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Shamrock guided by US/MR image fusion

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Lidocaine-epinephrine added gadoterate meglumine

Intervention Type 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

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

Group Type OTHER

Ultrasound guided lumbar plexus block (Shamrock)

Intervention Type PROCEDURE

Lidocaine-epinephrine added gadoterate meglumine

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Ultrasound guided lumbar plexus block (Shamrock)

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes