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

This study has been withdrawn prior to enrollment.
(Orthopedic surgeon that does our knee surgeries moved to a different location)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00616850
First received: February 4, 2008
Last updated: May 20, 2014
Last verified: May 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group A
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.
Experimental: Group B
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.
Placebo Comparator: Group C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Michelle Schlunt, M.D. Loma Linda University Medical Center
  More Information

No publications provided

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00616850     History of Changes
Other Study ID Numbers: 57175
Study First Received: February 4, 2008
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 24, 2014