Motor Sparing Block vs. Peri-Articular Catheters
|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.|
|ClinicalTrials.gov Identifier: NCT01503528|
Recruitment Status : Recruiting
First Posted : January 4, 2012
Last Update Posted : November 30, 2017
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 or disease||Intervention/treatment||Phase|
|Knee Joint Arthritis Knee Joint Arthroplasty||Procedure: Motor Sparing Nerve Block Procedure: Peri-articular Catheters||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|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)|
|Official Title:||Outcomes After Total Knee Joint Arthroplasty: A Comparative Study Using 3 Different Analgesic Techniques|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||January 2019|
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.
- 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.
- 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
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
|Contact: James Howard, FRCSC||519 685 8500 ext email@example.com|
|Contact: Bryn Zomar, MSc||519 685 8500 ext firstname.lastname@example.org|
|London Health Sciences Centre University Hospital||Recruiting|
|London, Ontario, Canada|
|Contact: Bryn Zomar, MSc 519 685 8500 ext 32794 email@example.com|
|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|
|Principal Investigator:||James Howard, FRCSC||Associate Professor, London Health Sciences Centre|