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How Lidocaine Affects Outcomes In Orthopedic Surgery Patients

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ClinicalTrials.gov Identifier: NCT01179100
Recruitment Status : Withdrawn (Patient population require high amount of opioids.)
First Posted : August 11, 2010
Last Update Posted : September 7, 2015
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Brief Summary:

This study will evaluate the effect of intraoperative lidocaine infusion on postoperative orientation and concentration in elderly patients having general anesthesia for orthopedic surgeries requiring a minimum 2 days hospitalization.

This study will also aim to determine whether intraoperative lidocaine infusion during general anesthesia improves recovery and patient outcome, as well as to determine whether lidocaine infusion decreases postoperative opioid (pain medication) usage.

Condition or disease Intervention/treatment Phase
General Anesthesia Surgeries Requiring A Minimum One Day Hospitalization Elderly Drug: Lidocaine Phase 4

Detailed Description:

Advances in surgical techniques and anesthetic care have resulted in a substantial reduction in peri-operative morbidity and mortality in the elderly. However, post-operative cognitive dysfunction (POCD), as well as episodic post-operative delirium, are still recognized as significant complications following surgery in the elderly. Post-operative cognitive dysfunction is characterized by impairment of memory, concentration, language, comprehension, and social integration. Conversely, post-operative delirium is characterized by intermittent, short-term impaired cognition, disorientation, and abnormalities in memory and perception, which has been shown to lead to increased morbidity and mortality, delayed functional recovery, and prolonged hospital stays. Elderly patients are particularly sensitive to the central nervous system effects of many peri-anesthetic drugs, including benzodiazepines, barbiturates, opioids, and volatile anesthetics, which may play a role in POCD and consequent patient outcomes. Randomized clinical trials have demonstrated no difference in the recovery of cognitive function between commonly used volatile anesthetic agents.

Several simple, bedside tests are available to assess cognitive function and differentiate between cognitive dysfunction and an episode of delirium. The Confusion Assessment Method (CAM) is a standardized rating of delirium that has been validated and has high inter-observer reliability. The CAM criteria are the most commonly used method for diagnosing delirium in hospitalized patients. The Mini-Mental Status Examination (MMSE) and the Abbreviated Mental Test are tools used to assess cognitive function at the bedside.

Lidocaine is one of the most commonly used sodium-channel blockers in the medical armamentarium. It has long been used for its local anesthetic and anti-arrhythmic properties, and has been studied as an adjunct to general anesthesia. While lidocaine is cardio-toxic in excessive doses, the therapeutic and toxic levels are well-documented and wide, making lidocaine a drug with a favorable safety profile. Randomized clinical trials have shown perioperative lidocaine infusions to decrease postoperative pain scores, reduce postoperative opioid requirements, shortens hospital stays, improves postoperative recovery and fatigue score when administered as an adjuvant during surgery. Lidocaine has analgesic, antihypertensive, and anti-inflammatory properties. To date, no clinical trials have been conducted to establish the relationship between lidocaine infusions and postoperative recovery, particularly cognitive function, in elderly orthopedic surgery patients. It is therefore the aim of this study to evaluate the effects of lidocaine infusion on postoperative cognitive function in elderly patients having general anesthesia for orthopedic surgery, and to assess whether intraoperative lidocaine infusion decreases postoperative opioid usage and improves recovery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Official Title: The Effects Of Lidocaine Infusion On The Recovery Of Cognitive Function Following General Anesthesia In Elderly Patients Undergoing Orthopedic Surgeries Requiring A Minimum Two Day Hospitalization
Study Start Date : June 2011
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Normal Saline
Normal Saline: Calculated and adjusted to match loading dose and infusion rate of lidocaine equivalent adjusted for weight.
Drug: Lidocaine
Lidocaine (10mg/ml) Loading: 1.5 mg/kg + Infusion: 0.035 mg/kg/min
Active Comparator: Lidocaine Drug: Lidocaine
Lidocaine (10mg/ml) Loading: 1.5 mg/kg + Infusion: 0.035 mg/kg/min

Primary Outcome Measures :
  1. Post-operative cognitive function [ Time Frame: 1 month ]
    Pre-operative cognitive function tests, including the CAM, MMSE, and the Abbreviated Mental Test, will be administered to establish baseline cognitive function. Then compared with the results of the postoperative cognitive function tests.

Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 1 month ]
    The postoperative pain will be measured during one month, using follow up questionnaires at 1, 2, or 3, then 7and 30 days after surgery

  2. Opioid consumption obtained from the recorded data [ Time Frame: 1 month ]
    Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery)

  3. Postoperative nausea and vomiting using a Verbal Rating Scale [ Time Frame: 1 month ]
    Nausea and vomiting will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery

  4. Return to normal activities of daily living using follow up questionnaires Return to normal activities of daily living using follow up questionnaires [ Time Frame: 1 month ]
    Return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)will be measured in both groups.

  5. Patient satisfaction using a verbal rating scale from 0 to 100 [ Time Frame: 1 month ]
    0= Not satisfied 100= Excellent

  6. Hospital stay [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Scheduled to undergo orthopedic surgery under general anesthesia requiring a minimum two-day hospitalization (e.g. THA, TKA, hardware removal)
  • 65 years of age or older
  • ASA Physical Classification I - IV
  • Willingness and ability to sign an informed consent document
  • English-speaking

Exclusion Criteria:

  • Inability to consent or complete cognitive assessments
  • Inability to use a PCA system
  • Allergy to lidocaine or any other medication administered as part of this protocol
  • Emergency surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179100

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Roya Yumul, MD, PhD Cedars-Sinai Medical Center

Responsible Party: Roya Yumul, M.D.,PhD., Residency program director, Department of anesthesiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01179100     History of Changes
Other Study ID Numbers: Pro00019834
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: September 7, 2015
Last Verified: September 2015

Keywords provided by Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center:
general anesthesia
lidocaine infusion
local anesthetic
pain management
cognitive function

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action