Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
James Howard, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01667445
First received: August 7, 2012
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Post-operative Pain
Osteoarthritis
Drug: Epimorph
Drug: Spinal analgesia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Determination of Effectiveness of Periarticular Local Infiltration When Compared to Spinal Epimorph for Analgesia in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • visual analogue scale for pain [ Time Frame: 1 week post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient report of nausea [ Time Frame: 48hours post-operatively ] [ Designated as safety issue: No ]
  • patient report of pruritus [ Time Frame: 48hours post-operatively ] [ Designated as safety issue: No ]
  • catheterization requirements [ Time Frame: 48hours post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: epimorph
single dose administration of 150mcg epimorph
Drug: Epimorph
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.
Other Names:
  • morphine sulfate
  • Duramorph PF
  • MS Contin
  • Roxano
Active Comparator: spinal analgesia
spinal alone
Drug: Spinal analgesia
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.
Other Name: Analgesia cocktail

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667445

Contacts
Contact: Katherine P Hrabok, BHSc, RMT 519-685-8500 ext 32794 katherine.hrabok@lhsc.on.ca
Contact: Abigail E Korczak, RN, BScN 519-685-8500 ext 32789 abigail.korczak@lhsc.on.ca

Locations
Canada, Ontario
University Hospital, London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Principal Investigator: James Howard, MD MSc FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: James L Howard, MD London Health Sciences Centre
  More Information

No publications provided

Responsible Party: James Howard, Orthopaedic surgeon, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01667445     History of Changes
Other Study ID Numbers: 102837
Study First Received: August 7, 2012
Last Updated: March 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
total knee arthroplasty
epimorph
analgesia

Additional relevant MeSH terms:
Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 26, 2014