The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Information source: Capital Health, Canada
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Total Knee Arthroplasty
Intervention: On-Q PainBuster with Bupivacaine (Device); Usual Care (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Capital Health, Canada Official(s) and/or principal investigator(s):
Gordon Arnett, MD, Principal Investigator, Affiliation: Capital Health, Canada
Overall contact:
Holly Meyer, MSc, Phone: 780-735-1119, Email: holly.meyer@capitalhealth.ca
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.
Clinical Details
Official title: The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Study design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain, measured by the 11-point numerical pain rating scale
Secondary outcome: Post-operative nausea and vomitingNarcotic medications taken Time to first mobilization, first transfer and first 30-M walk Number of adverse events Length of Stay Satisfaction (patient and caregiver)
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
Minimum age: 18 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Holly Meyer, MSc, Phone: 780-735-1119, Email: holly.meyer@capitalhealth.ca
Royal Alexandra Hospital, Edmonton, Alberta, Canada
Additional Information
Last updated: July 25, 2008
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