Analgesic Efficacy of Intravenous Lidocaine for Postoperative Pain Following Adult Spine Surgery

NCT01043211 | Withdrawn DMC

• 1 other identifier: F091105002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to generate further insight into the role and effectiveness of the amide local anesthetic lidocaine as an adjuvant postoperative analgesic after adult spine surgery. The effect of perioperative intravenous lidocaine infusion on postoperative rehabilitation and the inflammatory response will also be examined.

Conditions

Back Pain

Keywords

Back Pain; Lidocaine

Outcome Measures

Primary Outcomes (6)

• Postanesthesia care unit(PACU)admission duration (in minutes)

  Assessed after discharge from PACU

• Post extubation requirement for intravenous fentanyl in operating room (Y/N and mcg/kg)

  Post extubation

• Time to first nurse administered morphine dose after PACU admission (in minutes)

  Assessed after PACU admission

• Total dose of fentanyl administered intraoperatively (mcg/kg) and in the PACU (mcg/kg)

  Measured post op

• Total amount of mophine administered/PCA pump demands and doses and ratio of PCA demands/doses

  48-72 hours postoperative period

• Self reported VAS pain scores (on a 0-100 scale)

  Obtained on admissions to and upon discharge from PCAU, every 4 hours thereafter for the first 48 to 72 hours postoperatively, and at time of initial postoperative mobilization

Secondary Outcomes (4)

• Side effect analysis

  Measurements of side effect analysis will be done postoperatively

• Pain Intensity Questionnaires

  BPI-SF completed at time of initial and subsequent postop visits, Roland Morris Back Pain Questionnaire completed postop and 12-14 days, 3 mos, 6 mos, 12 mos, and 24 mos postop as compared to baseline value

• Length of hospital stay

  From admission to discharge

• Post rehab analysis

  Time to first liquid oral intake, time to initial mobilization, time to discontinuation of study solution infusion, time to discharge order, and to time to actual discharge home

Interventions

Lidocaine Hydrochoride Injection, without epinephrine DRUG

A standardized 0.2 ml/kg (2 mg/kg) intravenous bolus dose of lidocaine (1%, 10 mg/ml) is given after anesthetic induction but prior to skin incision. Immediately thereafter, lidocaine (1%, 10 mg/ml) will be administered on a standardized 0.3 ml/hr/kg (3 mg/kg/hr, maximum 200 mg/hr = 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the lidocaine infusion will be decreased by 50% to 0.15 ml/hr/kg (1.5 mg/kg/hr, maximum 100 mg/hr = 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).

Also known as: Xylocaine

Normal Saline DRUG

A standardized 0.2 ml/kg intravenous bolus dose of preservative-free normal saline will be given after anesthetic induction but prior to skin incision. Immediately thereafter, normal saline will be administered on an equal 0.3 ml/hr/kg (maximum 20 ml/hr) basis using a continuous infusion pump during the surgical procedure. Immediately after skin closure, the normal saline infusion will be decreased by 50% to 0.15 ml/hr/kg (maximum 10 ml/hr) and continued for 90 minutes postoperatively. The infusion will be stopped before the patient is discharged from the post-anesthesia care unit (PACU).

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 80 years of age
• American Society of Anesthesiologists 1-3 status
• Undergoing lumbar laminectomy between levels L1 and S1 for decompression of degenerative lumbar canal stenosis but without fusion or internal fixation performed

You may not qualify if:

• American Society of Anesthesiologists 4 status
• Previous spinal fusion surgery but patient may have undergone previous lumbar laminectomy or lumbar open discectomy
• Morbid obesity (BMI \> 40)
• Diagnosis of spinal metastatic cancer
• Presence of a severe or systemic bacterial infection
• Allergy to an amide local anesthetic or morphine sulfate
• History of a seizure disorder
• History of atrial or ventricular arrhythmia
• History of autonomic dysfunction (e.g., dysautonomia of diabetes)
• History of renal dysfunction, liver dysfunction or congestive heart failure
• History of substance abuse disorder
• History of major psychiatric disorder (e.g., depression, bipolar disorder, Axis II personality disorder, schizophrenia)
• Chronic opioid use of greater than 100 mg/day of morphine equivalents within 30 days prior to surgery
• Current use of a corticosteroid
• Use of a non-steroidal anti-inflammatory drug (NSAID), including low dose aspirin within the past 5 days

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; 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 Officials

• Thomas R Vetter, M.D., M.P.H

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: January 6, 2010
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-01

Locations

US (1)