Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
Primary Purpose
Total Knee Arthroplasty
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous femoral catheter block
Lidocaine
Preservative free normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring Total Knee Arthroplasty, Intravenous Lidocaine Infusion, Femoral Block Catheter
Eligibility Criteria
Inclusion Criteria:
- Undergoing a total knee arthroplasty
- Be American Society of Anesthesiologist physical status 1,2, or 3
- Be willing and capable of providing informed consent
- Be English speaking
Exclusion Criteria:
- Age greater than 80 years old or younger than 18 years old
- Congestive hear failure
- Hepatic insufficiency
- Neurological disorders
- Psychiatric disorders
- Steroid treatment
- History of atrial fibrillation
- Chronic pain disorder with opioid treatment
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).
Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.
Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.
Outcomes
Primary Outcome Measures
Total PCA opioid consumption
Secondary Outcome Measures
Time to first flatus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00616850
Brief Title
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
Official Title
Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Orthopedic surgeon that does our knee surgeries moved to a different location
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty
Keywords
Total Knee Arthroplasty, Intravenous Lidocaine Infusion, Femoral Block Catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.
Intervention Type
Procedure
Intervention Name(s)
Continuous femoral catheter block
Intervention Description
A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
Intervention Type
Other
Intervention Name(s)
Preservative free normal saline
Intervention Description
Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
Primary Outcome Measure Information:
Title
Total PCA opioid consumption
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Time to first flatus
Time Frame
72 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing a total knee arthroplasty
Be American Society of Anesthesiologist physical status 1,2, or 3
Be willing and capable of providing informed consent
Be English speaking
Exclusion Criteria:
Age greater than 80 years old or younger than 18 years old
Congestive hear failure
Hepatic insufficiency
Neurological disorders
Psychiatric disorders
Steroid treatment
History of atrial fibrillation
Chronic pain disorder with opioid treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Schlunt, M.D.
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
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