Total Knee ArthroplastyNCT00616850
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
A study testing Continuous femoral catheter block, Lidocaine and Preservative free normal saline in people with Total Knee Arthroplasty, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Continuous femoral catheter block, Lidocaine and Preservative free normal saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jul 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
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.
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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Continuous femoral catheter block, Lidocaine, Preservative free normal saline
- Keywords
- Total Knee Arthroplasty, Intravenous Lidocaine Infusion, Femoral Block Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous femoral catheter blockProcedure or surgery
A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.
LidocaineDrug
Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
Preservative free normal salineOther
Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA). Receives: Procedure: Continuous femoral catheter block |
| Group B | Experimental | Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia. Receives: Drug: Lidocaine |
| Group C | Placebo comparator | Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia. Receives: Other: Preservative free normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total PCA opioid consumption
Measured: 72 hours
Secondary outcomes (1)
Time to first flatus
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2009
Why it stopped: Orthopedic surgeon that does our knee surgeries moved to a different location
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.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Schlunt, M.D., Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616850
- Sponsor's protocol ID
- 57175
- Status last verified
- May 2014
- First submitted
- 4 Feb 2008
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00616850
- Acronym / sponsor ID
- 57175
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Intravenous Lidocaine Infusion, Femoral Block Catheter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Orthopedic surgeon that does our knee surgeries moved to a different location
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Continuous femoral catheter blockGroup A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA). |
| Group B | Experimental | Drug: LidocaineGroup B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia. |
| Group C | Placebo comparator | Other: Preservative free normal salineGroup C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Age greater than 80 years old or younger than 18 years old
- Congestive hear failure
- Hepatic insufficiency
- Neurological disorders
- Psychiatric disorders
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 |
|---|---|---|
| Continuous femoral catheter blockA constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A. | Procedure or surgery | Group A |
| LidocaineLidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively. | Drug | Group B |
| Preservative free normal salinePreservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively. | Other | Group C |
Primary outcome
Total PCA opioid consumption
Time frame: 72 hours
1 secondary outcome
Time to first flatus
Time frame: 72 hours postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Michelle Schlunt, M.D. principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous femoral catheter block, Lidocaine and Preservative free normal saline in people with Total Knee Arthroplasty, run by Loma Linda University at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 May 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total PCA opioid consumption (time frame: 72 hours). 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 22 May 2014.