Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks (Echostim1)
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|ClinicalTrials.gov Identifier: NCT01492660|
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : April 23, 2013
Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups.
Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by electrical nerve stimulation. Group 2 will have the block performed using a Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for catheter location.
An observer blinded to the needle type will assess the quality of needle visualisation on a recording of the US image taken during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate, block performance time, complication rate, number of needle passes per block, and adequacy of spread of local anesthetic.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Knee Postoperative Pain||Device: echogenic needle and catheter Device: Neurostimulation to position needle and catheter||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Experimental: Echogenic needle and catheter
The echogenic needle will be positioned using ultrasonography and neurostimulation with an end point of plantar or dorsiflexion with 0.6mA of current strength. The catheter will be inserted using ultrasonography alone. 20 Ml of 2% mepivacaine will be inserted using the catheter. The distribution of drug will be evaluated using short axis and long axis views. Sensory motor block evaluation every 5 minutes for 30 minutes. Duration of block procedure, number of passes and success will be evaluated
Device: echogenic needle and catheter
Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip
Active Comparator: Neurostimulation
The non echogenic needle will be positioned using ultrasonography and neurostimulation with plantar or dorsiflexion as the end point with 0.6mA current.The catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current.
Device: Neurostimulation to position needle and catheter
The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins
Other Name: Pajunk Stimulaong Plexus catheter set
- Visibility of needle tip and catheter tip [ Time Frame: Day 1 ]Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers
- number of needle passes [ Time Frame: Day 1 ]The number of times the needle is withdrawn more than 2 cm and resited
- success rate of block [ Time Frame: Day 1 ]Motor and sensory block will be evaluated on standard grading system every 5 minutes for 30 minutes post injection
- Block procedure time [ Time Frame: Day 1 ]Time from needle insertion to the end of catheter insertion
- Immediate complications [ Time Frame: Day 1 ]Vascular punctures, venous or arterial
- delayed complications [ Time Frame: One week after surgery/block ]telephone interview to elicit delayed neurologic symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492660
|London Health Sciences Centre University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Principal Investigator:||Sugantha Ganapathy||Professor, Director, regional and Pain reseaerch|