Clinical Trial Results:
Shamrock – Ultrasound/MR image fusion guided lumbar plexus blocks
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Summary
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EudraCT number |
2015-005544-33 |
Trial protocol |
DK |
Global end of trial date |
10 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Dec 2016
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First version publication date |
16 Dec 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
AUH-TFB-SR-ULMR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02718976 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Thomas Fichtner Bendtsen
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Sponsor organisation address |
Dep. of Anesthesiology and Intensive Care, Aarhus University Hospital, Nørrebrogade 44, Aarhus C, Denmark, DK-8000
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Public contact |
Clinical Trial Info: Shamrock US/MRI, Thomas Fichtner Bendtsen, 45 51542997, tfb@dadlnet.dk
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Scientific contact |
Clinical Trial Info: Shamrock US/MRI, Thomas Fichtner Bendtsen, 45 51542997, tfb@dadlnet.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Oct 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess lumbar plexus block (L2-L4) of the femoral, obturator, and lateral femoral cutaneous nerves with ultrasound/MRI image fusion guided Shamrock method vs. ultrasound guided Shamrock method in a blinded, randomized controlled trial. The lumbar plexus block is assessed as motor block of the femoral and obturator nerves and sensory block of the lateral femoral cutaneous nerve in healthy volunteers.
As an exploratory analysis, patterns of injectate spread with MRI were examined.
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Protection of trial subjects |
The trial subjects were asked about their general well-being and any prior disease and discomfort during enrollment and upon arrival to as well as departure from the trial venue on each experimental day.
The trial subjects were monitored with 3-lead electrocardiography, non-invasive blood pressure, and pulse oximetry from five minutes before the pre-scan to five minutes after completed intervention. During each intervention, the research anesthetist and the assistent communicated with the trial subject reassuring his/her well-being. Immediately after completed intervention, the maximal discomfort of the trial subject during the procedure was assessed on a numeric rating scale (NRS 0-10). All trial subjects were observed for adverse reactions until the sensorimotor effects had worn off.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Mar 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
All volunteers were recruited through a Danish website for research volunteers in the period 8 to 31 March 2016. | |||||||||
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Pre-assignment
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Screening details |
22 volunteers were screened and 22 volunteers were included in the study. | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [1] | |||||||||
Roles blinded |
Data analyst, Assessor | |||||||||
Blinding implementation details |
In addition we strived to blind the trial subjects with identical trial setup.
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Arms
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Are arms mutually exclusive |
No
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Arm title
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Shamrock US/MRI | |||||||||
Arm description |
All included trial subjects received a lumbar plexus block with the Shamrock technique guided by ultrasound/MRI fusion either on the first or the second trial day (randomized). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Lidokain-adrenalin SAD
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
20 ml 2% lidocaine with 0.0005% adrenaline was injected.
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Investigational medicinal product name |
Dotarem
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion in pre-filled syringe
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Routes of administration |
Perineural use
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Dosage and administration details |
0.13 ml Dotarem (279.3 mg gadoterate meglumine) was added to the lidocaine-adrenaline prior to injection in order to enhance visualization of the anatomical spread of lidocaine-adrenaline on MRI after the intervention.
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Arm title
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Shamrock US | |||||||||
Arm description |
All included trial subjects received a lumbar plexus block with the Shamrock technique guided by ultrasound either on the first or the second trial day (randomized). | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Lidokain-adrenalin SAD
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Perineural use
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Dosage and administration details |
20 ml 2% lidocaine with 0.0005% adrenaline was injected.
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Investigational medicinal product name |
Dotarem
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion in pre-filled syringe
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Routes of administration |
Perineural use
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Dosage and administration details |
0.13 ml Dotarem (279.3 mg gadoterate meglumine) was added to the lidocaine-adrenaline prior to injection in order to enhance visualization of the anatomical spread of lidocaine-adrenaline on MRI after the intervention.
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| Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The observers and analysts of data were blinded and we strived to blind the trial subjects with identical trial setup and by not revealing the type (US/MRI or MRI guided) intervention during the trial. |
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Shamrock US/MRI
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Reporting group description |
All included trial subjects received a lumbar plexus block with the Shamrock technique guided by ultrasound/MRI fusion either on the first or the second trial day (randomized). | ||
Reporting group title |
Shamrock US
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Reporting group description |
All included trial subjects received a lumbar plexus block with the Shamrock technique guided by ultrasound either on the first or the second trial day (randomized). | ||
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End point title |
Block success | |||||||||
End point description |
Proportion of trial subjects with successful lumbar plexus blockade. A block was considered successful when the subject had motor blockade of the femoral and obturator nerves and sensory blockade of the lateral femoral cutaneous nerve. Motor blockade was defined as post-block muscle force < baseline muscle force of knee extension (femoral nerve) and hip adduction (obturator nerve), respectively. Sensory blockade was defined as decreased or absent sensation for cold and/or pain.
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End point type |
Primary
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End point timeframe |
Baseline muscle force and sensory for cold and pain was assessed upon arrival on the first experimental day. Post-block muscle force was assessed 60 min after and sensory blockade 70 min after completed intervention.
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Statistical analysis title |
Block success | |||||||||
Comparison groups |
Shamrock US/MRI v Shamrock US
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.69 | |||||||||
Method |
Mcnemar | |||||||||
Parameter type |
Difference in paired proportions | |||||||||
Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
-0.35 | |||||||||
upper limit |
0.17 | |||||||||
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End point title |
Motor block | |||||||||||||||
End point description |
Number of subjects with successful motor blockade of the femoral and obturator nerves, respectively. A successful motor blockade was defined as post-block muscle force < baseline muscle force of knee extension (femoral nerve) and hip adduction (obturator nerve), respectively.
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End point type |
Secondary
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End point timeframe |
Baseline muscle force was assessed upon arrival on the first experimental day. Post-block muscle force was assessed 60 min after completed intervention.
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Block preparation time | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Assessed prior to intervention. Defined as the time from placement of the subject on the bed to completed pre-scanning and co-registration of ultrasound and MRI.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Block procedure time | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Assessed as the time from placement of the probe on the skin after completed preparations to withdrawal of the block needle after completed injection.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Lumbar plexus ultrasonographically visualized | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Assessed immediately prior to the injection.
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| No statistical analyses for this end point | ||||||||||
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End point title |
Minimal electrical nerve stimulation | ||||||||||||
End point description |
The minimum electrical nerve stimulation level in mA required to trigger a response was measured in order to confirm the position of the block needle tip before injection.
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End point type |
Secondary
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End point timeframe |
Assessed immediately prior to injection.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Response on electrical nerve stimulation | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Assessed immediately prior to injection.
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of needle insertions | ||||||||||||
End point description |
The number of block needle insertions was defined as the number of retractions of the block needle followed by advancement regardless of the number of skin insertions.
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End point type |
Secondary
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End point timeframe |
Counted from the start of the block procedure time to the end of injection.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Needle insertion point from midline | ||||||||||||
End point description |
The block needle insertion point was estimated as the horizontal distance (cm) from the needle insertion point in the skin to the lumbar midline.
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End point type |
Secondary
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End point timeframe |
Measured immediately after completed injection.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Needle depth | ||||||||||||
End point description |
The distance from skin to the block needle tip was estimated as the distance (cm) from the block needle insertion point in the skin to the block needle tip gauged by reading of the cm markings on the needle shaft.
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End point type |
Secondary
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End point timeframe |
Measured immediately prior to injection of study medicine.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Procedural discomfort | ||||||||||||
End point description |
Assessed immediately after completed intervention.
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End point type |
Secondary
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End point timeframe |
The trial subject's discomfort during block procedure was assessed on a numeric rating scale (NRS) 0- 10, where 0 = no discomfort and 10 = worst possible discomfort.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change in mean arterial pressure (MAP) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
ΔMAP was measured as the change of MAP from the time immediately prior to pre-scanning to 5 minutes after completed intervention.
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Perineural spread of injectate | ||||||||||||||||||||||||||||||||||||
End point description |
Perineural spread of local anesthetic was assessed as present when visual contact between the local anesthetic and the nerve on MRI was confirmed.
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End point type |
Secondary
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End point timeframe |
Assessed by MRI recorded 15 min after completed injection.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Epidural spread of injectate | |||||||||
End point description |
Epidural spread was assessed to be present when circumferential epidural spread of the injectate was observed on MRI and decreased or absent sensation for cold was observed in at least one pair of bilateral dermatomes during the sensory mapping.
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End point type |
Secondary
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End point timeframe |
Epidural spread of local anesthetics was assessed on MRI sampled 15 minutes after completed intervention and during sensory mapping 70 minutes after completed intervention.
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| No statistical analyses for this end point | ||||||||||
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End point title |
Sensory blockade - Cold | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Sensory block for cold in the dermatomes Th8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for cold was decreased/absent.
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End point type |
Secondary
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End point timeframe |
Assessed 70 minutes after completed intervention.
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Sensory blockade - Warmth | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Sensory block for warmth in the dermatomes Th8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for warmth was decreased/absent.
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End point type |
Secondary
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End point timeframe |
Assessed 70 minutes after completed intervention.
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Sensory blockade - Touch | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Sensory block for touch in the dermatomes Th8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for touch was decreased/absent.
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End point type |
Secondary
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End point timeframe |
Assessed 70 minutes after completed intervention.
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Sensory blockade - Pain | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Sensory block for pinprick (pain) in the dermatomes Th8-S3 and in the skin area innervated by the lateral femoral cutaneous nerve, respectively, was assessed as present when the somatosensation for pinprick was decreased/absent.
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End point type |
Secondary
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End point timeframe |
Assessed 70 minutes after completed intervention.
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Cost-effectiveness | ||||||||||||
End point description |
Cost-effectiveness of the interventions was estimated as the difference in mean marginal cost for the ultrasound/MRI fusion vs. the ultrasound guided Shamrock technique.
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End point type |
Secondary
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End point timeframe |
Calculated in the end of the data analysis after last subject last visit.
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Continuous and systematic assessment of adverse events from upon arrival to discharge on each experimental day. All trial subjects were urged to self-report any adverse events between the experimental days and after discharge.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Shamrock US/MRI
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Shamrock US
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
