Clinical trial NCT00724074: The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Official title: The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Arthritis of the knee
Knee replacement
Osteoarthritis, knee
Arthroplasty, knee
Lead sponsor: Capital Health, Canada
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain, measured by the 11-point numerical pain rating scale
timeFrame: Post-operatively for three days then again at follow-up
Secondary outcomes:
measure: Post-operative nausea and vomiting
timeFrame: Post-operatively for three days
measure: Narcotic medications taken
timeFrame: Post-operatively for three days
measure: Time to first mobilization, first transfer and first 30-M walk
timeFrame: Up to three days post-operatively
measure: Number of adverse events
timeFrame: Three days post-op (observed) then at follow-up (self-report)
measure: Length of Stay
timeFrame: Time of surgery to discharge
measure: Satisfaction (patient and caregiver)
timeFrame: Discharge from hospital
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: Capital Health, Canada
name: Gordon Arnett, MD
role: PRINCIPAL_INVESTIGATOR
References: