How Lidocaine Affects Outcomes In Orthopedic Surgery Patients

NCT01179100 | Withdrawn Phase 4

• 1 other identifier: Pro00019834
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia; Surgeries Requiring A Minimum One Day Hospitalization; Elderly

Keywords

elderly; general anesthesia; lidocaine infusion; lidocaine; local anesthetic; pain management; cognitive function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative pain

  1 month

• Opioid consumption obtained from the recorded data

  1 month

• Postoperative nausea and vomiting using a Verbal Rating Scale

  1 month

• Return to normal activities of daily living using follow up questionnaires Return to normal activities of daily living using follow up questionnaires

  1 month

• Patient satisfaction using a verbal rating scale from 0 to 100

  1 month

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Normal Saline: Calculated and adjusted to match loading dose and infusion rate of lidocaine equivalent adjusted for weight.

Drug: Lidocaine

Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

Lidocaine DRUG

Lidocaine (10mg/ml) Loading: 1.5 mg/kg + Infusion: 0.035 mg/kg/min

Lidocaine; Normal Saline

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Roya Yumul, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residency program director, Department of anesthesiology

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: August 11, 2010
• Study Start: June 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (1)