The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
- Conditions
- Total Knee Arthroplasty
- Interventions
- Device: On-Q PainBuster with BupivacaineDevice: Usual Care
- Registration Number
- NCT00724074
- Lead Sponsor
- Capital Health, Canada
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- Deemed unfit for continuous wound infusion due to allergies
- Other exclusion criteria to be determined
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S On-Q PainBuster with Bupivacaine Patients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively. C Usual Care Usual care - post operative pain medications as per the knee arthroplasty care map.
- Primary Outcome Measures
Name Time Method Pain, measured by the 11-point numerical pain rating scale Post-operatively for three days then again at follow-up
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada