Effect of Perioperative Intravenous Lidocaine on Postoperative Quality of Recovery in Patients Undergoing Spine Surgery
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01930877
- Run by
- Baylor College of Medicine
- People needed
- 0
- Starts
- 2013-08-01
- Last updated by the study team
- 2015-10-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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).
Where it is running
- Ben Taub General Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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