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Clinical Trials/NCT00724074
NCT00724074UnknownNot Applicable

The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Capital Health, Canada1 site in 1 country20 target enrollmentStarted: July 29, 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Pain, measured by the 11-point numerical pain rating scale

Study 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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • ASA risk classification of 1 or 2
  • Do not regularly use opioid medication pre-operatively
  • Have preoperative knee range of motion > 90 degrees
  • Body Mass Index < 40
  • No known hepatic or liver insufficiency

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)

Investigators

Sponsor
Capital Health, Canada
Sponsor Class
Other

Study Sites (1)

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