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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01930877
• Other study ID #: H-32510
• Status: Withdrawn
• Phase: Phase 2
• First received: August 26, 2013
• Last updated: September 29, 2015
• Start date: August 2013

Study information

• Verified date: September 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Lidocaine iv bolus followed by infusion

Other:
• Placebo (normal saline)
Normal saline bolus followed by infusion

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Narcotic consumption		24 hours after surgery	No
Primary	Quality of recovery		At 24 hours after surgery	Yes
Secondary	Post operative pain		for the first 24 hours after surgery	No