The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

July 25, 2008 updated by: Capital Health, Canada
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Royal Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S
Patients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively.
Device: On-Q PainBuster with Bupivacaine
On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic
Active Comparator: C
Usual care - post operative pain medications as per the knee arthroplasty care map.
Device: Usual Care
Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain, measured by the 11-point numerical pain rating scale
Time Frame: Post-operatively for three days then again at follow-up
Post-operatively for three days then again at follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Health, Canada

Investigators

  • Principal Investigator: Gordon Arnett, MD, Capital Health, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 25, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • garnett

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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