The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: On-Q PainBuster with Bupivacaine
* Device: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S<br>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<br>* On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic<br>|
| Active Comparator: C<br>Usual care - post operative pain medications as per the knee arthroplasty care map. | Device: Usual Care<br>* Usual Care<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis of the knee, Knee replacement, Osteoarthritis, knee, Arthroplasty, knee