Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion (Lidocaine)

Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery

Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several studies have indicated that appropriate pain treatment protocols reduce postoperative morbidity, improve the results of the surgery, and decrease hospital costs

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: 0.9% Sodium-chloride

Detailed Description

Forty four patients were randomly allocated into two groups of equal size to receive either lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

Randomization: was performed using Lidocaine group and Control group registers, which was placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a physician who prepared the intravenous solution and identified it with the patient number, according to the envelope drawn. The solution was handed to another physician, blind to the prepared solutions' content, who was responsible for the anesthesia. The solution volume was equal. The responsible investigator was remained blind to the chosen group until the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut university faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age > 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation

Exclusion Criteria:

1. Previous spinal fusion surgery.
2. Morbid obesity (BMI > 40)
3. Diagnosis of spinal metastatic cancer
4. Allergy to an amide local anesthetic or morphine sulfate
5. History of renal dysfunction, liver dysfunction or congestive heart failure
6. History of substance abuse disorder.
7. Chronic opioid use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine group; Patients will receive lidocaine infusion.	Drug: Lidocaine; patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.; Other Names: Xylocaine
Placebo Comparator: Control group; Patients will receive 0.9% Sodium-chloride infusion infusion	Drug: 0.9% Sodium-chloride; patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numerical rating scale (NRS), pain score.	Postoperative numerical rating scale (NRS), pain score.	Postoperative 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption.	Postoperative opioid consumption.	Postoperative 24 h
Serum cortisol.	Serum cortisol level.	Postoperative 24 h

Collaborators and Investigators

• Sponsor: Abdelrady S Ibrahim, MD
• Investigators: Principal Investigator: Mohamed G Abdelraheem, MD, Assiut University

Publications and helpful links

General Publications

• de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 22, 2017
• First Submitted That Met QC Criteria: January 22, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRB0000871239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No