Total Knee ArthroplastyNCT00724074
The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
A study testing On-Q PainBuster with Bupivacaine in people with Total Knee Arthroplasty, run by Capital Health, Canada at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- On-Q PainBuster with Bupivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Deemed unfit for continuous wound infusion due to allergies
- Other exclusion criteria to be determined
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- On-Q PainBuster with Bupivacaine, Usual Care
- Keywords
- Arthritis of the knee, Knee replacement, Osteoarthritis, knee, Arthroplasty, knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-Q PainBuster with BupivacaineDevice
On-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic
Usual CareDevice
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| S | Experimental | Patients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively. Receives: Device: On-Q PainBuster with Bupivacaine |
| C | Active comparator | Usual care - post operative pain medications as per the knee arthroplasty care map. Receives: Device: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, measured by the 11-point numerical pain rating scale
Measured: Post-operatively for three days then again at follow-up
Secondary outcomes (6)
Post-operative nausea and vomiting
Measured: Post-operatively for three days
Narcotic medications taken
Measured: Post-operatively for three days
Time to first mobilization, first transfer and first 30-M walk
Measured: Up to three days post-operatively
Number of adverse events
Measured: Three days post-op (observed) then at follow-up (self-report)
Length of Stay
Measured: Time of surgery to discharge
Satisfaction (patient and caregiver)
Measured: Discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Health, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Gordon Arnett, MD, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724074
- Sponsor's protocol ID
- garnett
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Wound Infusion Analgesia in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00724074
- Acronym / sponsor ID
- garnett
- Conditions
- Total Knee Arthroplasty
- Keywords
- Arthritis of the knee, Knee replacement, Osteoarthritis, knee, Arthroplasty, knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Health, CanadaUniversity, hospital or other
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S | Experimental | Device: On-Q PainBuster with BupivacainePatients receive the On-Q local continuous wound infusion system intra-operatively and use it for up to three days post-operatively. |
| C | Active comparator | Device: Usual CareUsual care - post operative pain medications as per the knee arthroplasty care map. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (2 listed)
- Deemed unfit for continuous wound infusion due to allergies
- Other exclusion criteria to be determined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-Q PainBuster with BupivacaineOn-Q PainBuster continuous wound infusion analgesia system, using bupivacaine as the local anaesthetic | Device | S |
| Usual CareUsual Care | Device | C |
Primary outcome
Pain, measured by the 11-point numerical pain rating scale
Time frame: Post-operatively for three days then again at follow-up
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Arnett, MD principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Q PainBuster with Bupivacaine in people with Total Knee Arthroplasty, run by Capital Health, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly Meyer, MSc (780-735-1119, holly.meyer@capitalhealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, measured by the 11-point numerical pain rating scale (time frame: Post-operatively for three days then again at follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2008.