The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 29, 2008
CompletedJuly 29, 2008
July 1, 2008
July 25, 2008
July 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain, measured by the 11-point numerical pain rating scale
Post-operatively for three days then again at follow-up
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
S
EXPERIMENTALPatients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively.
C
ACTIVE COMPARATORUsual care - post operative pain medications as per the knee arthroplasty care map.
Interventions
On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Deemed unfit for continuous wound infusion due to allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Alexandra Hospital
Edmonton, Alberta, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon Arnett, MD
Capital Health, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 29, 2008
Last Updated
July 29, 2008
Record last verified: 2008-07