Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery

The Effect of Perioperative Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery: A Randomized, Double - Blinded, Placebo Controlled Study

Acute postoperative pain is an unpleasant, unwanted sensory and emotional experience for the patient. The investigators seek to determine if the addition of systemic lidocaine can improve the quality of recovery after spine surgery and reduce the requirement for opiate therapy.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine; Other: Placebo (normal saline)

Detailed Description

Consented patients will be randomized to either saline group or lidocaine group. General anesthesia will be induced as it would normally be done in any patient undergoing spine surgery. Once the patient is positioned for the surgery bolus followed by the infusion of either the study drug or the placebo will be administered. The infusion will be stopped at the end of surgery and the patient will be transferred to the post anesthesia care unit. Post operative pain score will be evaluated for the first 24 hrs and also the amount of pain medications used will be recorded. At the end of 24 hours quality of recovery will be assessed using a qor-40 questionnaire.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients age 18-80 yrs;
2. American Society of Anesthesiology Physical Status I, II or III; and
3. Patients undergoing thoracic or lumbosacral spine surgeries with or without instrumentation via the posterior approach with planned admission to the post anesthesia care unit after surgery-

Exclusion Criteria:

1. Allergy to any of the study medications or anesthetic agents used in the study;
2. American Society of Anesthesiology physical status IV;
3. Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
4. History of severe hepatic dysfunction with liver enzymes elevated to more than 3 times the normal or International normalized ratio of more than 2 and renal dysfunction with GFR less than 60 ml/min
5. History of previous spinal fusion or instrumentation;
6. Diagnosis of cancer of the spine;
7. History of surgery for abscess or osteomyelitis;
8. History of cardiac dysrhythmia or heart block;
9. History of chronic heroin or methadone use;
10. Preoperative use of any systemic corticosteroid;
11. History of seizure disorder; and
12. Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr	Drug: Lidocaine; Lidocaine iv bolus followed by infusion
Placebo Comparator: Placebo; Normal saline placebo infusion	Other: Placebo (normal saline); Normal saline bolus followed by infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of recovery	At 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Post operative pain	for the first 24 hours after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Narcotic consumption	24 hours after surgery

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: quality of recovery; spine surgery; intravenous lidocaine
• 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: H-32510