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Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
This study is currently recruiting participants.
Study NCT00616850   Information provided by Loma Linda University
First Received: February 4, 2008   Last Updated: May 12, 2009   History of Changes

February 4, 2008
May 12, 2009
October 2007
July 2008   (final data collection date for primary outcome measure)
Total PCA opioid consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616850 on ClinicalTrials.gov Archive Site
Time to first flatus [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ]
Same as current
 
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study
Total Knee Arthroplasty
  • Procedure: Continuous femoral catheter block
  • Drug: Lidocaine
  • Other: Preservative free normal saline
  • Active Comparator: Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).
  • Experimental: Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.
  • Placebo Comparator: Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
99
 
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Undergoing a total knee arthroplasty
  2. Be American Society of Anesthesiologist physical status 1,2, or 3
  3. Be willing and capable of providing informed consent
  4. Be English speaking

Exclusion Criteria:

  1. Age greater than 80 years old or younger than 18 years old
  2. Congestive hear failure
  3. Hepatic insufficiency
  4. Neurological disorders
  5. Psychiatric disorders
  6. Steroid treatment
  7. History of atrial fibrillation
  8. Chronic pain disorder with opioid treatment
Both
18 Years to 80 Years
No
 
United States
 
NCT00616850
Michelle Schlunt, M.D., Loma Linda University Medical Center, Department of Anesthesia
57175
Loma Linda University
 
Principal Investigator: Michelle Schlunt, M.D. Loma Linda University Medical Center
Loma Linda University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP