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Motor Sparing Block vs. Peri-Articular Catheters

This study is currently recruiting participants.
Verified October 2017 by James Howard, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503528
First Posted: January 4, 2012
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
James Howard, Lawson Health Research Institute
  Purpose

This study is designed to determine if one anaesthetic modality, either motor sparing nerve block or peri-articular local infiltration anaesthesia with infusion, is superior in providing postoperative analgesia following total knee joint arthroplasty and if the efficacy of analgesia affects TKA outcomes. These outcomes include pain and function for a period of up to 3 months, narcotic consumption, and specific non-pain complications, including cardiac, respiratory, central nervous system, thromboembolism, infection, nausea and vomiting and urinary retention.

Economic outcomes will also be examined, including length of hospital stay, direct health care costs and patient satisfaction.


Condition Intervention Phase
Knee Joint Arthritis Knee Joint Arthroplasty Procedure: Motor Sparing Nerve Block Procedure: Peri-articular Catheters Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a prospective randomized clinical trial. For safety and logistical reasons, it cannot be blinded. In the perioperative period multiple factors contribute to discharge readiness. The major impediments to early discharge include poor pain control, opioid related adverse events, surgical/ medical complications, inability to achieve physiotherapy end points and patient's unwillingness to be discharged. We want to compare head to head, two previously evaluated fast-track paradigms. We are not comparing just the analgesic technique alone. We are comparing the pathways where the analgesic regimes are a component and differ, keeping the common factors similar between the groups. If a technique does not allow early ambulation, patients cannot be ready for discharge and thus resource utilization will be affected.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes After Total Knee Joint Arthroplasty: A Comparative Study Using 3 Different Analgesic Techniques

Further study details as provided by James Howard, Lawson Health Research Institute:

Primary Outcome Measures:
  • Primary outcome - Perioperative pain [ Time Frame: day of surgery to 2 weeks post-op ]
    Postoperative pain levels on a visual analogue scale will be recorded while the patient is an inpatient up to a maximum of 4 days post-discharge, and again at 2 weeks post-op.


Secondary Outcome Measures:
  • Readiness and True Discharge times [ Time Frame: in-patient period ]
    Readiness for discharge and the actual time of discharge will be recorded

  • Postoperative mobility/function [ Time Frame: Measured on day of surgery to discharge day 4. Functional outcomes will be collected at 6 weeks and 3 months post-op using WOMAC and KSS scores ]
    Postoperative mobility will be assessed by a physiotherapist, and recorded using inpatient assessment notes and patient recorded physiotherapy progression following discharge in their pain diary.

  • Analgesia/Narcotic Consumption [ Time Frame: day of surgery to post-discharge day 4 ]
    Break-through/rescue analgesia and narcotics that were consumed between assessment intervals will be documented

  • Complications [ Time Frame: day of surgery to 3 months post-op ]
    Post-operative complications such as myocardial events, DVT, Pulmonary emboli, delirium, pneumonia, paralytic ileus, gastrointestinal bleed, new onset renal dysfunction and wound infection

  • Nausea and Sedation symptoms [ Time Frame: day of surgery to post-discharge day 4 ]
    Analgesic side-effects will be monitored and compared to narcotic consumption

  • Patient reported pain, stiffness and functional disability. [ Time Frame: Assessed preoperatively, and at 6 weeks and 3 months postoperative. ]
    These variables will be assesed using the Knee Society Score and Western Ontario and McMaster Universities Arthritis Index (WOMAC score).

  • Short-From Survey-12 [ Time Frame: Assessed preoperatively, and at 6 weeks and 3 months postoperative. ]
    Overall assessment of patient's health

  • Anaesthetic Procedure Performance Data [ Time Frame: peri-operatively ]
    Block performance characteristics prospectively collected will include procedural time, success, number of attempts and complications such as persistent paresthesia and intravascular injection


Estimated Enrollment: 70
Actual Study Start Date: October 16, 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Motor Sparing Nerve Block
Motor sparing knee block (60mL of 0.5% ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room as per the standard practice and continued until discharge. Spinal anesthetic with 15 mg of hyperbaric bupivacaine. Patients will be connected to an Ambit infusion pump in the postoperative period set to deliver ropivacaine 0.2% at a basal infusion rate of 7 mL/Hr with patient controlled boluses of 5mL every hour for breakthrough pain. Patients will be discharged home following removal of the anaesthetic catheter and fulfilling criteria for discharge.
Procedure: Motor Sparing Nerve Block
Continuous Motor sparing knee block (60mL of 0.5% ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room as per the standard practice and continued until discharge. Patients will be connected to an Ambit infusion pump in the postoperative period set to deliver ropivacaine 0.2% at a basal infusion rate of 7 mL/Hr with patient controlled boluses of 5mL every hour for breakthrough pain.
Experimental: Peri-Articular Catheters
3 peri-articular catheters inserted at the end of surgery followed by peri-articular infiltration with ropivacaine 0.2% and wound infusions will be continued until discharge using elastomeric devices. Spinal anesthetic with 15 mg of hyperbaric bupivacaine. Patients will be discharged home following removal of the anaesthetic catheter and fulfilling criteria for discharge.
Procedure: Peri-articular Catheters
3 peri-articular catheters inserted at the end of surgery followed by periarticular infiltration with ropivacaine 0.2% and wound infusions will be continued until discharge using elastomeric devices.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult patients ASA physical status 1-3, Ability to give informed consent, No contraindications to regional techniques, Ability to perform study related tests, Scheduled for primary unilateral total knee arthroplasty

Exclusion Criteria:

Revision of arthroplasty, Allergy to local anesthetics and multimodal analgesic drugs, Contraindications to spinal anesthesia, Inability to perform study related procedures, Inability to give informed consent, Wheel chair bound, Pregnancy, Chronic renal failure, BMI >45

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01503528


Contacts
Contact: James Howard, FRCSC 519 685 8500 ext 33551 james.howard@lhsc.on.ca
Contact: Bryn Zomar, MSc 519 685 8500 ext 32794 bryn.zomar@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre University Hospital Recruiting
London, Ontario, Canada
Contact: Bryn Zomar, MSc    519 685 8500 ext 32794    bryn.zomar@lhsc.on.ca   
Sub-Investigator: Edward Vasarhelyi, MD, FRCSC         
Sub-Investigator: Brent Lanting, MD, FRCSC         
Sub-Investigator: Peter Mack, MD, FRCPC         
Sub-Investigator: Mahesh Nagappa, MD, FRCPC         
Sub-Investigator: James Allen, MB, BCh         
Sub-Investigator: Deepti Vissa, DNB         
Sub-Investigator: Sugantha Ganapahty, FRCPC         
Sub-Investigator: Bryn Zomar, MSc         
Principal Investigator: James Howard, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: James Howard, FRCSC Associate Professor, London Health Sciences Centre
  More Information

Responsible Party: James Howard, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01503528     History of Changes
Other Study ID Numbers: 18448
101754 ( Other Identifier: Research and ethics board, University of Western Ontario )
First Submitted: January 2, 2012
First Posted: January 4, 2012
Last Update Posted: October 20, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Howard, Lawson Health Research Institute:
arthroplasty
wound
catheter
local
anesthesia
infiltration
Total Knee Arthroplasty

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents