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

NCT01930877 | Withdrawn Phase 2

• 1 other identifier: H-32510
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

quality of recovery; spine surgery; intravenous lidocaine

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  At 24 hours after surgery

Secondary Outcomes (1)

• Post operative pain

  for the first 24 hours after surgery

Other Outcomes (1)

• Narcotic consumption

  24 hours after surgery

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Normal saline placebo infusion

Other: Placebo (normal saline)

Interventions

Lidocaine DRUG

Lidocaine iv bolus followed by infusion

Lidocaine

Placebo (normal saline) OTHER

Normal saline bolus followed by infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-80 yrs;
• American Society of Anesthesiology Physical Status I, II or III; and
• 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-

You may not qualify if:

• Allergy to any of the study medications or anesthetic agents used in the study;
• American Society of Anesthesiology physical status IV;
• Spine surgery with the expected duration of surgery being more than 4 hours as determined by the attending surgeon;
• 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
• History of previous spinal fusion or instrumentation;
• Diagnosis of cancer of the spine;
• History of surgery for abscess or osteomyelitis;
• History of cardiac dysrhythmia or heart block;
• History of chronic heroin or methadone use;
• Preoperative use of any systemic corticosteroid;
• History of seizure disorder; and
• Patient inability to properly describe postoperative pain to investigators (dementia, delirium, psychiatric disorder).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: October 1, 2015

Record last verified: 2015-09

Locations

US (1)