How Lidocaine Affects Outcomes In Orthopedic Surgery Patients
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.
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 Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver)
Conditions
Orthopedic
Intervention
Lidocaine
Location
Cedars Sinai Medical Center
Los Angeles
California
United States
90048
Status
Enrolling by invitation
Source
Cedars-Sinai Medical Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01179100
- Information obtained from ClinicalTrials.gov on March 13, 2012
Medical and Biotech [MESH] Definitions
Orthopedic Equipment
Nonexpendable items used in the performance of orthopedic surgery and related therapy. They are differentiated from ORTHOTIC DEVICES, apparatus used to prevent or correct deformities in patients.
Orthopedic Fixation Devices
Devices which are used in the treatment of orthopedic injuries and diseases.
Orthopedic Nursing
The specialty or practice of nursing in the care of the orthopedic patient.
Manipulation, Orthopedic
The planned and carefully managed manual movement of the musculoskeletal system, extremities, and spine to produce increased motion. The term is sometimes used to denote a precise sequence of movements of a joint to determine the presence of disease or to reduce a dislocation. In the case of fractures, orthopedic manipulation can produce better position and alignment of the fracture. (From Blauvelt & Nelson, A Manual of Orthopaedic Terminology, 5th ed, p264)
Mexiletine
Antiarrhythmic agent pharmacologically similar to LIDOCAINE. It may have some anticonvulsant properties.
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