The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Total Knee Arthroplasty |
Device: On-Q PainBuster with Bupivacaine Device: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty |
- Pain, measured by the 11-point numerical pain rating scale [ Time Frame: Post-operatively for three days then again at follow-up ] [ Designated as safety issue: No ]
- Post-operative nausea and vomiting [ Time Frame: Post-operatively for three days ] [ Designated as safety issue: Yes ]
- Narcotic medications taken [ Time Frame: Post-operatively for three days ] [ Designated as safety issue: Yes ]
- Time to first mobilization, first transfer and first 30-M walk [ Time Frame: Up to three days post-operatively ] [ Designated as safety issue: Yes ]
- Number of adverse events [ Time Frame: Three days post-op (observed) then at follow-up (self-report) ] [ Designated as safety issue: Yes ]
- Length of Stay [ Time Frame: Time of surgery to discharge ] [ Designated as safety issue: No ]
- Satisfaction (patient and caregiver) [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Holly Meyer, MSc | 780-735-1119 | holly.meyer@capitalhealth.ca |
| Contact: Gordon Arnett, MD | 780-455-5115 | garnett@edmontonortho.ca |
| Canada, Alberta | |
| Royal Alexandra Hospital | Not yet recruiting |
| Edmonton, Alberta, Canada | |
| Principal Investigator: Gordon Arnett, MD | |
| Principal Investigator: | Gordon Arnett, MD | Capital Health, Canada |
More Information
No publications provided
| Responsible Party: | Dr. Gordon Arnett, Capital Health |
| ClinicalTrials.gov Identifier: | NCT00724074 History of Changes |
| Other Study ID Numbers: | garnett |
| Study First Received: | July 25, 2008 |
| Last Updated: | July 25, 2008 |
| Health Authority: | Canada: University of Alberta and Capital Health |
Keywords provided by Capital Health, Canada:
|
Arthritis of the knee Knee replacement Osteoarthritis, knee Arthroplasty, knee |
Additional relevant MeSH terms:
|
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013