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Clinical Trials/NCT00724074
NCT00724074
Unknown
Not Applicable

The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Capital Health, Canada1 site in 1 country20 target enrollmentJuly 29, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Capital Health, Canada
Enrollment
20
Locations
1
Primary Endpoint
Pain, measured by the 11-point numerical pain rating scale
Last Updated
17 years ago

Overview

Brief Summary

The main purpose of this study is to determine if there is improvement in pain and other patient outcomes when using a continuous wound analgesia system after total knee replacement, compared to usual methods of pain control. Another purpose is to determine if the system makes it easier for nurses to care for these patients.

Detailed Description

Continuous local wound infusion analgesia is a relatively new way of managing post-operative pain, whereby a local anesthetic is continuously infused into the surgical area. Some studies and users have reported decreased pain, decreased opioid use, decreased post-operative nausea and vomiting, decreased length of stay, and improved patient and caregiver satisfaction with the use of continuous local wound infusion analgesia, when compared to placebo, or usual care, in arthroplasty and other surgical interventions. Hypotheses: Primary: The On-Q PainBuster (continuous wound infusion analgesia) in TKA will result in improved patient pain control, compared to usual care. Secondary: * Pain scores post-operatively will be better than usual care. * Fewer narcotics will be ingested post-operatively than with usual care. * Post-op nausea and vomiting will be less than usual care. * Length of stay will be shorter compared to usual care. * Patient satisfaction will be greater than satisfaction with usual care. * Post-operative infection rates will be no different between groups. * Fall rates will be no different between groups. * Subjects will participate in physical therapy the day of surgery. * Nursing Intensity requirements will be less with the wound infusion due to fewer requests for pain medication.

Registry
clinicaltrials.gov
Start Date
July 29, 2008
End Date
TBD
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Capital Health, Canada

Eligibility Criteria

Inclusion Criteria

  • Scheduled for TKA at the Royal Alexandra Hospital
  • Patient of Dr. Arnett
  • Deemed fit for continuous wound infusion (no allergies to Bupivacaine or related medications) by anesthesia
  • Cognitively aware, and provides informed consent
  • Elective (not trauma-related) surgery
  • Able to read, speak and understand English
  • Adult \< 70 years of age
  • Intra-operative spinal anaesthesia
  • Reside within metropolitan Edmonton, in a bungalow
  • Have a caregiver at home

Exclusion Criteria

  • Deemed unfit for continuous wound infusion due to allergies
  • Other exclusion criteria to be determined

Outcomes

Primary Outcomes

Pain, measured by the 11-point numerical pain rating scale

Time Frame: Post-operatively for three days then again at follow-up

Secondary Outcomes

  • Post-operative nausea and vomiting(Post-operatively for three days)
  • Narcotic medications taken(Post-operatively for three days)
  • Time to first mobilization, first transfer and first 30-M walk(Up to three days post-operatively)
  • Number of adverse events(Three days post-op (observed) then at follow-up (self-report))
  • Length of Stay(Time of surgery to discharge)
  • Satisfaction (patient and caregiver)(Discharge from hospital)

Study Sites (1)

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