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Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty

This study is currently recruiting participants.
Verified October 2012 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: October 17, 2012
Last verified: October 2012
History of Changes
  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
Total Knee Arthroplasty
 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:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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
Active Comparator: spinal analgesia
spinal alone
 Drug: spinal analgesia

  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 Analagesia
  • Revision total knee arthroplasty
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667445

Contacts
Contact: Julie E Todd, RN BScN 519-685-8500 ext 32794 julie.todd@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
  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: October 17, 2012
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on May 16, 2013