Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks (Echostim1)
This study has been completed.
Sponsor:
Lawson Health Research Institute
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Sugantha Ganapathy, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01492660
First received: October 11, 2011
Last updated: April 19, 2013
Last verified: January 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Knee Postoperative Pain |
Device: echogenic needle and catheter Device: Neurostimulation to position needle and catheter |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- Visibility of needle tip and catheter tip [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers
Secondary Outcome Measures:
- number of needle passes [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]The number of times the needle is withdrawn more than 2 cm and resited
- success rate of block [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Time from needle insertion to the end of catheter insertion
- Immediate complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]Vascular punctures, venous or arterial
- delayed complications [ Time Frame: One week after surgery/block ] [ Designated as safety issue: Yes ]telephone interview to elicit delayed neurologic symptoms
| Enrollment: | 70 |
| Study Start Date: | January 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients age 18-80 years listed for total knee arthroplasty.
- ASA I-IV.
- Able to give informed consent
- Able to cooperate with study protocol.
Exclusion Criteria:
- Standard contraindication to regional anaesthesia/analgesia: local infection, coagulopathy, local anaesthetic allergy, patient refusal, diabetes mellitus, peripheral neuropathy, pre-existing nerve injury)
- Inability to consent
- Patient refusal
- Pregnant patients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492660
Locations
| Canada, Ontario | |
| London Health Sciences Centre University Hospital | |
| London, Ontario, Canada, N6A 5A5 | |
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Investigators
| Principal Investigator: | Sugantha Ganapathy | Professor, Director, regional and Pain reseaerch |
More Information
No publications provided
| Responsible Party: | Sugantha Ganapathy, Professor, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01492660 History of Changes |
| Other Study ID Numbers: | R-11-495, 17757 |
| Study First Received: | October 11, 2011 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
Ultrasonography nerve block catheters needle anesthesia |
Additional relevant MeSH terms:
|
Osteoarthritis Pain, Postoperative Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013