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Hip FracturesPhase 2NCT02718976

Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block

A Phase 2 study testing Lidocaine-epinephrine added gadoterate meglumine in people with Hip Fractures and Anesthesia, Local, run by University of Aarhus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
Lidocaine-epinephrine added gadoterate meglumine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
No sites listed yet
Study dates
Mar 2016to Apr 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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

About this study

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.

Being tested
Ultrasound/MR image fusion guided lumbar plexus block (Shamrock), Ultrasound guided lumbar plexus block (Shamrock), Lidocaine-epinephrine added gadoterate meglumine
Keywords
Hip surgery anesthesia, Perioperative analgesia
Medical subject headings
Hip Fractures, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • Ultrasound guided lumbar plexus block (Shamrock)Procedure or surgery

  • Lidocaine-epinephrine added gadoterate meglumineDrug

    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.

Study groups in NCT02718976
Study groupRoleWhat they receive
Shamrock guided by US/MR image fusionExperimentalUse of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Receives: Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock); Drug: Lidocaine-epinephrine added gadoterate meglumine
Shamrock guided by USOtherUse of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine).
Receives: Procedure: Ultrasound guided lumbar plexus block (Shamrock); Drug: Lidocaine-epinephrine added gadoterate meglumine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.

Secondary outcomes (16)

  1. 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.

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

  2. 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).

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

  3. 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.

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

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

    Type of neuromuscular response on electrical nerve stimulation.

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

  5. Needle advancements

    Number of needle advancements during intervention.

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

  6. Injection site

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

  7. Block needle depth

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

  8. Discomfort

    Estimated on numeric rating scale 0-10

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

  9. Mean arterial pressure change

    Measured: Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.

  10. 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

    Measured: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.

  11. Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.

    Measured: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.

  12. 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.

    Measured: 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.

  13. 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.

    Measured: Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.

  14. Cost-effectiveness (ICER)

    ICER is estimated as the difference in mean marginal cost of the blocks.

    Measured: Calculated 1 month after study completion. Data will be presented 10 months after study completion.

  15. Quantitative diffusion weighted MRI reproducibility

    Measured: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.

  16. Image evaluation of diffusion weighted MRI reproducibility

    Measured: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02718976
Sponsor's protocol ID
AUH-TFB-SR-ULMR
Status last verified
Feb 2016
First submitted
22 Feb 2016
Last updated
26 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine-epinephrine added gadoterate meglumine in people with Hip Fractures and Anesthesia, Local, run by University of Aarhus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Assessed 60 minutes after intervention. Data will be presented 10 months after study completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02718976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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