Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
Determination of Effectiveness of Periarticular Local Infiltration When Compared to Spinal Epimorph for Analgesia in Total Knee Arthroplasty
1 other identifier
interventional
113
1 country
1
Brief Summary
The purpose of this study is to determine the contribution of spinal epimorph to patient's perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to determine whether spinal epimorph and its associated complications is a necessary addition to provide adequate analgesia given the multimodal approach to pain management. It is hypothesized that perioperative local infiltration with a cocktail of local and systemic analgesics will provide equal analgesia to patients who are given both local infiltration and spinal epimorph perioperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 postoperative-pain
Started Sep 2012
Typical duration for phase_4 postoperative-pain
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
August 7, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedApril 28, 2015
April 1, 2015
2 years
August 7, 2012
April 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analogue scale for pain
1 week post-operatively
Secondary Outcomes (3)
patient report of nausea
48hours post-operatively
patient report of pruritus
48hours post-operatively
catheterization requirements
48hours post-operatively
Study Arms (2)
epimorph
EXPERIMENTALsingle dose administration of 150mcg epimorph
spinal analgesia
ACTIVE COMPARATORspinal alone
Interventions
Patient to receive 150ug of Epimorph with Spinal anaesthetic. Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.
Patient to receive only Spinal anaesthetic (NO EPIMORPH). Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.
Eligibility Criteria
You may qualify if:
- Patients must receive a primary total knee arthroplasty
You may not qualify if:
- Inability to have a spinal anaesthetic
- Intolerance to narcotic pain medication
- Inability to use a Patient Controlled Analgesia
- Revision total knee arthroplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James L Howard, MD
London Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic surgeon
Study Record Dates
First Submitted
August 7, 2012
First Posted
August 17, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
April 28, 2015
Record last verified: 2015-04