Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks (Echostim1)

This study has been completed.
Sponsor:
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
  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:
  • Pajunk Stimulong plexus catheter set
  • Pajunk sonolong sonoset
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014