How Lidocaine Affects Outcomes In Orthopedic Surgery Patients

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Elderly; General Anesthesia; Surgeries Requiring A Minimum One Day Hospitalization
• Intervention / Treatment: Drug: Lidocaine

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine	Drug: Lidocaine; Lidocaine (10mg/ml) Loading: 1.5 mg/kg + Infusion: 0.035 mg/kg/min
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative cognitive function	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption obtained from the recorded data	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)	1 month
Patient satisfaction using a verbal rating scale from 0 to 100	0= Not satisfied 100= Excellent	1 month
Postoperative pain	The postoperative pain will be measured during one month, using follow up questionnaires at 1, 2, or 3, then 7and 30 days after surgery	1 month
Postoperative nausea and vomiting using a Verbal Rating Scale	Nausea and vomiting will be measured with follow up questionnaires at 1, 2, or 3, then 7 and 30 days after surgery	1 month
Return to normal activities of daily living using follow up questionnaires Return to normal activities of daily living using follow up questionnaires	Return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities)will be measured in both groups.	1 month
Hospital stay		1 week

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): September 7, 2015
• Last Update Submitted That Met QC Criteria: September 3, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: lidocaine; cognitive function; elderly; general anesthesia; pain management; local anesthetic; lidocaine infusion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Pro00019834