Evaluation of Motor Sparing Knee Block to Infiltration Analgesia for Pain Following Knee Arthroplasty
Ultrasound Guided Motor Sparing Knee Blocks With or Without Dexmedetomidine for Postoperative Analgesia Following Knee Arthroplasty: a Randomized Double Blinded Study
1 other identifier
interventional
135
1 country
1
Brief Summary
Patients undergoing primary total knee replacement will receive either motor sparing knee block to be performed by anesthesia or periarticular local anesthetic infiltration at the end of surgery by surgeons to assess pain relief as well as capacity to ambulate early. The motor sparing knee block will be performed prior to surgery using ultrasonography and the effect of adding dexmedetomidine, an alpha 2 agonist to the injectate with regards to prolonging the duration of analgesia will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedNovember 15, 2016
August 1, 2015
3.3 years
March 17, 2014
November 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of analgesia
To note the duration of analgesia in the three different arms
24 postoperative hour
Secondary Outcomes (3)
pain scores on movement
every 4 hours up to 24 hours
pain scores at rest
every 4 hours up to 24 hours
discharge criteria
6 and 18 postoperative hours
Study Arms (3)
Periarticular
ACTIVE COMPARATORPatients in group 1 will receive periarticular infiltration of LA mixture (100 ml) consisting of 0.3% ropivacaine, 2.5 µg/mL of epinephrine, 10 mg of morphine and 30 mg of ketorolac at the end of surgery and sham injections of saline into the motor sparing knee blocks preoperatively.
Motor free
EXPERIMENTALPatients in group 2 will receive motor sparing knee blocks with 0.5% ropivacaine with 2.5 µg/mL of epinephrine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Sham injections of saline (100 ml) will be injected periarticularly at the end of surgery.
Motor free with Dex
EXPERIMENTALPatients in group 3 will receive motor sparing knee blocks with 0.5% ropivacaine with 1 µg/Kg of dexmedetomidine, 30 mg of ketorolac and 10 mg of morphine with a total local anesthetic volume of 60 ml (300 mg). Patients in group 3 will receive sham injections of saline (100 ml) periarticularly at the end of surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Male and females of 18-85 years of age, scheduled to undergo elective primary total knee arthroplasty.
- ASA Class I, II, III
- Good contralateral leg strength
You may not qualify if:
- ASA physical status 4 or above
- Patients who will need hospitalization due to reason other than the planned surgery.
- Psychiatric illnesses.
- Revision knee surgery
- Narcotic dependency
- Extraneous sources of chronic pain
- Inability to provide informed consent.
- Allergy to any of the drugs used in the study.
- Contraindications to blocks and multimodal analgesia
- Wheel chair bound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Related Publications (2)
Fowler SJ, Christelis N. High volume local infiltration analgesia compared to peripheral nerve block for hip and knee arthroplasty-what is the evidence? Anaesth Intensive Care. 2013 Jul;41(4):458-62. doi: 10.1177/0310057X1304100404.
PMID: 23808503BACKGROUNDAbdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth. 2013 Jun;110(6):915-25. doi: 10.1093/bja/aet066. Epub 2013 Apr 15.
PMID: 23587874BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sugantha Ganapathy, FRCPC
LHSC, UWO, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2014
First Posted
September 3, 2015
Study Start
August 1, 2014
Primary Completion
December 1, 2017
Last Updated
November 15, 2016
Record last verified: 2015-08