Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion - Full Text View

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Nausea and Vomiting

Drug Information available for: Lidocaine

U.S. FDA Resources

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:

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

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

No publications provided

Responsible Party:	Loma Linda University Medical Center, Department of Anesthesia ( Michelle Schlunt, M.D. )
Study ID Numbers:	57175
Study First Received:	February 4, 2008
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00616850 History of Changes
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:

Ropivacaine
Lidocaine
Anesthetics
Central Nervous System Depressants
Pain
Cardiovascular Agents
Anesthetics, Local

Signs and Symptoms
Postoperative Complications
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Epinephrine
Pain, Postoperative

Additional relevant MeSH terms:

Physiological Effects of Drugs
Lidocaine
Anesthetics
Central Nervous System Depressants
Pain
Cardiovascular Agents
Anesthetics, Local
Pharmacologic Actions
Signs and Symptoms

Pathologic Processes
Postoperative Complications
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on September 10, 2009