The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Capital Health, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Capital Health, Canada
ClinicalTrials.gov Identifier:
NCT00724074
First received: July 25, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Capital Health, Canada:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724074

Contacts
Contact: Holly Meyer, MSc 780-735-1119 holly.meyer@capitalhealth.ca
Contact: Gordon Arnett, MD 780-455-5115 garnett@edmontonortho.ca

Locations
Canada, Alberta
Royal Alexandra Hospital Not yet recruiting
Edmonton, Alberta, Canada
Principal Investigator: Gordon Arnett, MD         
Sponsors and Collaborators
Capital Health, Canada
Investigators
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 October 01, 2014