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Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion

This study is currently recruiting participants.
Verified by Loma Linda University, August 2008

Sponsored by: Loma Linda University
Information provided by: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616850
  Purpose

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.


Condition Intervention
Total Knee Arthroplasty
Procedure: Continuous femoral catheter block
Drug: Lidocaine
Other: Preservative free normal saline

MedlinePlus related topics:   Knee Replacement    Nausea and Vomiting   

ChemIDplus related topics:   Sodium chloride    Ropivacaine    Ropivacaine Hydrochloride    Ropivacaine monohydrochloride    Lidocaine    Epinephrine    Epinephrine bitartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy 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.

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Total PCA opioid consumption [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first flatus [ Time Frame: 72 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:   99
Study Start Date:   October 2007
Estimated Primary Completion Date:   July 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group A: Active Comparator
Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).
Procedure: Continuous femoral catheter block
A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.
Group B: Experimental
Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.
Drug: Lidocaine
Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
Group C: Placebo Comparator
Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.
Other: Preservative free normal saline
Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616850

Locations
United States, California
Loma Linda University Medical Center     Recruiting
      Loma Linda, California, United States, 92354
      Contact: Pat Moore     909-558-8493        
      Sub-Investigator: Jonathan Kelling, M.D.            

Sponsors and Collaborators
Loma Linda University

Investigators
Principal Investigator:     Michelle Schlunt, M.D.     Loma Linda University Medical Center    
  More Information


Responsible Party:   Loma Linda University Medical Center, Department of Anesthesia ( Michelle Schlunt, M.D. )
Study ID Numbers:   57175
First Received:   February 4, 2008
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00616850
Health Authority:   United States: Institutional Review Board

Keywords provided by Loma Linda University:
Total Knee Arthroplasty  
Intravenous Lidocaine Infusion  
Femoral Block Catheter  

Study placed in the following topic categories:
Signs and Symptoms
Postoperative Complications
Ropivacaine
Lidocaine
Pain
Epinephrine
Pain, Postoperative

Additional relevant MeSH terms:
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on October 07, 2008




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