The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00724074
• Other study ID #: garnett
• Status: Not yet recruiting
• Phase: N/A
• First received: July 25, 2008
• Last updated: July 25, 2008

Study information

• Verified date: July 2008
• Source: Capital Health, Canada
• Contact: Holly Meyer, MSc
• Phone: 780-735-1119
• Email: holly.meyer[@]capitalhealth.ca
• Is FDA regulated: No
• Health authority: Canada: University of Alberta and Capital Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• On-Q PainBuster with Bupivacaine
On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic
• Usual Care
Usual Care

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Capital Health, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, measured by the 11-point numerical pain rating scale		Post-operatively for three days then again at follow-up	No
Secondary	Post-operative nausea and vomiting		Post-operatively for three days	Yes
Secondary	Narcotic medications taken		Post-operatively for three days	Yes
Secondary	Time to first mobilization, first transfer and first 30-M walk		Up to three days post-operatively	Yes
Secondary	Number of adverse events		Three days post-op (observed) then at follow-up (self-report)	Yes
Secondary	Length of Stay		Time of surgery to discharge	No
Secondary	Satisfaction (patient and caregiver)		Discharge from hospital	No