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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00724074
Other study ID # garnett
Secondary ID
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
Est. completion date
Est. primary completion date
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


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
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Active, not recruiting NCT04850300 - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses Phase 3
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Enrolling by invitation NCT05130216 - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
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Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Completed NCT01616836 - Optimizing Pain and Rehabilitation After Knee Arthroplasty Phase 3
Withdrawn NCT01511211 - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic Phase 4
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Completed NCT00985920 - Topical Tranexamic Acid for Total Knee Arthroplasty Phase 4
Completed NCT00761956 - A Study to Compare the NexGen CR and CR-Flex Knee Implants N/A
Completed NCT03289247 - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty N/A
Terminated NCT03316118 - US Guided GNB vs Saline Injection for TKA Phase 4
Recruiting NCT05962970 - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty N/A
Completed NCT03317834 - Navio With Total Knee Arthroplasty
Enrolling by invitation NCT06188091 - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty N/A