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

Phase 2

Withdrawn

• Conditions: Pain
• Interventions: Other: Placebo (normal saline); Drug: Lidocaine

• Registration Number: NCT01930877
• Lead Sponsor: Baylor College of Medicine

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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-28
• Study First Posted: 2013-08-29
• Primary Completion: 2014-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (normal saline)	Normal saline placebo infusion
Lidocaine	Lidocaine	Intravenous Lidocaine bolus of 1.5 mg/kg followed by infusion of 1.5 mg/kg/hr

Primary Outcome Measures

Name	Time	Method
Quality of recovery	At 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Post operative pain	for the first 24 hours after surgery

Trial Locations

Locations (1)

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States