The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT00724074|
Recruitment Status : Unknown
Verified July 2008 by Capital Health, Canada.
Recruitment status was: Not yet recruiting
First Posted : July 29, 2008
Last Update Posted : July 29, 2008
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Device: On-Q PainBuster with Bupivacaine Device: Usual Care||Not Applicable|
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.
The On-Q PainBuster (continuous wound infusion analgesia) in TKA will result in improved patient pain control, compared to usual care.
- 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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty|
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
- Pain, measured by the 11-point numerical pain rating scale [ Time Frame: Post-operatively for three days then again at follow-up ]
- Post-operative nausea and vomiting [ Time Frame: Post-operatively for three days ]
- Narcotic medications taken [ Time Frame: Post-operatively for three days ]
- Time to first mobilization, first transfer and first 30-M walk [ Time Frame: Up to three days post-operatively ]
- Number of adverse events [ Time Frame: Three days post-op (observed) then at follow-up (self-report) ]
- Length of Stay [ Time Frame: Time of surgery to discharge ]
- Satisfaction (patient and caregiver) [ Time Frame: Discharge from hospital ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724074
|Contact: Holly Meyer, MScemail@example.com|
|Contact: Gordon Arnett, MDfirstname.lastname@example.org|
|Royal Alexandra Hospital||Not yet recruiting|
|Edmonton, Alberta, Canada|
|Principal Investigator: Gordon Arnett, MD|
|Principal Investigator:||Gordon Arnett, MD||Capital Health, Canada|