Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
Primary Purpose
Post-operative Pain, Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Epimorph
Spinal analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring total knee arthroplasty, epimorph, analgesia
Eligibility Criteria
Inclusion Criteria:
- Patients must receive a primary total knee arthroplasty
Exclusion Criteria:
- Inability to have a spinal anaesthetic
- Intolerance to narcotic pain medication
- Inability to use a Patient Controlled Analgesia
- Revision total knee arthroplasty
Sites / Locations
- University Hospital, London Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
epimorph
spinal analgesia
Arm Description
single dose administration of 150mcg epimorph
spinal alone
Outcomes
Primary Outcome Measures
visual analogue scale for pain
Secondary Outcome Measures
patient report of nausea
patient report of pruritus
catheterization requirements
Full Information
NCT ID
NCT01667445
First Posted
August 7, 2012
Last Updated
April 27, 2015
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01667445
Brief Title
Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
Official Title
Determination of Effectiveness of Periarticular Local Infiltration When Compared to Spinal Epimorph for Analgesia in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This will be a randomized control trial comparing two patient populations obtained from patients who will receive a primary total knee arthroplasty at LHSC University Campus. Patient participants will be recruited and consented from the arthroplasty clinic and from the preadmit clinic at University Hospital. Both the patients and those measuring the primary outcome, namely, visual pain scales will be blinded to the experimental treatment received.
Patients will be randomized to receive either a spinal with epimorph (150ug) or a spinal with no epimorph at the time of their total hip arthroplasty. This is determined as a result of a computer generated randomization within blocks of 10 (every 10 patients there will be an even number of patients within each group). As each patient signs up they are given a consecutive study number which will determine which group they are assigned to. Note should be made that at the current time patients undergoing total joint arthroplasty may or may not receive epimorph preoperatively depending on their anaesthesiologist (personal communication with Sue Ganapathy) and so both treatment arms represent the current standard of care at LHSC. Again, spinal epimorph is currently being administered for total joint replacement, irregardless of whether or not this study is being done. It is an acceptable standard of care analgesic that is available to each anesthetist should they choose to use it. Many choose to use it as they feel it improves analgesia in patients undergoing total joint arthroplasty, which are recognized as very painful procedures (especially total knees). This is no different that one anesthetist preferring to use dilaudid for pain control and another choosing to use morphine. Both are within accepted standard of care guidelines and it is up to the individual staff to utilize the drug they feel is most beneficial. This decision is based on each individual consultant's interpretation of the available literature as well as their personal practice experience. I hope this justifies our study as we are not introducing any new treatment. Patients will receive spinal epimorph whether or not we conduct this study. As such, no formal study discontinuation rules are applicable. Both patient groups will receive medical treatment as required around the time of their procedure.
Both groups of patients will receive standardized preoperative analgesia including gabapentin (600mg), acetaminophen (975 mg) and naprosyn (500mg). Both groups will receive local anaesthesia in the form of local infiltration of the wound with a previously studied cocktail of morphine, ketoralac, epinephrine and ropivicaine. (3) Post operatively patients will remain on PCA until post operative day one and then will be changed to a standardized oral protocol including long and short acting narcotics on a PRN basis, acetaminophen (975 mg Q6h x 48hrs and then on a PRN basis), naproxyn (500mg BID x 7 days) and gabapentin (300mg BID x 7 days).
Postoperatively visual analogue pain scales will be recorded at 6, 12, 18, 24, 36 and 48hrs as well as at 1 week. Foley usage, oxygen usage, nausea/vomiting and use of antiemetics and antipruritics will also be carefully documented. Both patient groups will receive the standard post operative physiotherapy and will be discharged home with a prescription for the narcotic or analgesics that were providing them with suitable analgesia during their hospital stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Osteoarthritis
Keywords
total knee arthroplasty, epimorph, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
epimorph
Arm Type
Experimental
Arm Description
single dose administration of 150mcg epimorph
Arm Title
spinal analgesia
Arm Type
Active Comparator
Arm Description
spinal alone
Intervention Type
Drug
Intervention Name(s)
Epimorph
Other Intervention Name(s)
morphine sulfate, Duramorph PF, MS Contin, Roxano
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Spinal analgesia
Other Intervention Name(s)
Analgesia cocktail
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual analogue scale for pain
Time Frame
1 week post-operatively
Secondary Outcome Measure Information:
Title
patient report of nausea
Time Frame
48hours post-operatively
Title
patient report of pruritus
Time Frame
48hours post-operatively
Title
catheterization requirements
Time Frame
48hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must receive a primary total knee arthroplasty
Exclusion Criteria:
Inability to have a spinal anaesthetic
Intolerance to narcotic pain medication
Inability to use a Patient Controlled Analgesia
Revision total knee arthroplasty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L Howard, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty
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