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.
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
- Conditions the study is for
- Hip Fractures, Anesthesia, Local, Pain, Postoperative
- 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
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- 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.
- Conditions
- Hip Fractures, Anesthesia, Local, Pain, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). 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.
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)
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.
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.
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.
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.
Needle advancements
Number of needle advancements during intervention.
Measured: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Injection site
Measured: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Block needle depth
Measured: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Discomfort
Estimated on numeric rating scale 0-10
Measured: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
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.
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.
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.
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.
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.
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.
Quantitative diffusion weighted MRI reproducibility
Measured: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
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.
- First posted24 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Bendtsen, Thomas Fichtner, M.D, Ph.D., AP Moeller Foundation, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jennie MC Strid, M.D., Principal investigator, Department of Anesthesiology and Intensive Care, Aarhus University Offical
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shamrock - Ultrasound/MR Image Fusion Guided Lumbar Plexus Block
- ClinicalTrials.gov ID
- NCT02718976
- Acronym / sponsor ID
- AUH-TFB-SR-ULMR
- Conditions
- Hip Fractures, Anesthesia, Local, Pain, Postoperative
- Keywords
- Hip surgery anesthesia, Perioperative analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Bendtsen, Thomas Fichtner, M.D, Ph.D., AP Moeller Foundation, Aarhus University Hospital
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shamrock guided by US/MR image fusion | Experimental | Procedure: Ultrasound/MR image fusion guided lumbar plexus block (Shamrock), Drug: Lidocaine-epinephrine added gadoterate meglumineUse of US/MR image fusion guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine). |
| Shamrock guided by US | Other | Procedure: Ultrasound guided lumbar plexus block (Shamrock), Drug: Lidocaine-epinephrine added gadoterate meglumineUse of US guided Shamrock technique to place lumbar plexus block (20 ml 2% lidocaine with epinephrine added gadoterate meglumine). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound/MR image fusion guided lumbar plexus block (Shamrock) | Procedure or surgery | Shamrock guided by US/MR image fusion |
| Ultrasound guided lumbar plexus block (Shamrock) | Procedure or surgery | Shamrock guided by US |
| Lidocaine-epinephrine added gadoterate megluminePerineural 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. | Drug | Shamrock guided by US, Shamrock guided by US/MR image fusion |
Primary outcome
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.
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.
16 secondary outcomes
Time for preparation of block procedure (seconds)
Time frame: Assessed 3 minutes prior to intervention. Data will be presented 10 months after study completion.
Time for block procedure (seconds)
Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Electrical nerve stimulation strength (mA)
Time frame: 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)
Time frame: Assessed 1 minute before injection of injectate. Data will be presented 10 months after study completion.
Needle advancements
Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Injection site
Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Block needle depth
Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Discomfort
Time frame: Assessed 0 minutes after intervention. Data will be presented 10 months after study completion.
Mean arterial pressure change
Time frame: Mean arterial pressure is measured prior to intervention and 5 min after intervention. Data will be presented 10 months after study completion.
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
Time frame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
Number of participants with visually confirmed epidural spread of the injectate assessed on MRI.
Time frame: Assessed on MRI sampled 10-40 minutes after intervention. Data will be presented 10 months after study completion.
Number of participants with motor block
Time frame: 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.
Number of participants with sensory block
Time frame: Estimated 70 minutes after intervention. Data will be presented 10 months after study completion.
Cost-effectiveness (ICER)
Time frame: Calculated 1 month after study completion. Data will be presented 10 months after study completion.
Quantitative diffusion weighted MRI reproducibility
Time frame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
Image evaluation of diffusion weighted MRI reproducibility
Time frame: Assessed on MRI sampled 40-55 minutes after intervention. Data will be presented 10 months after study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennie MC Strid, M.D. principal investigator
Department of Anesthesiology and Intensive Care, Aarhus University Offical
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?
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.