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Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion (Lidocaine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030560
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Lidocaine Drug: 0.9% Sodium-chloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery
Actual Study Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Normal saline




Primary Outcome Measures :
  1. numerical rating scale (NRS), pain score. [ Time Frame: Postoperative 3 months ]
    Postoperative numerical rating scale (NRS), pain score.


Secondary Outcome Measures :
  1. opioid consumption. [ Time Frame: Postoperative 24 h ]
    Postoperative opioid consumption.

  2. Serum cortisol. [ Time Frame: Postoperative 24 h ]
    Serum cortisol level.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030560


Locations
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Egypt
Assiut university faculty of medicine
Assiut, Egypt
Sponsors and Collaborators
Abdelrady S Ibrahim, MD
Investigators
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Principal Investigator: Mohamed G Abdelraheem, MD Assiut University
Publications:
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Responsible Party: Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT03030560    
Other Study ID Numbers: IRB0000871239
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action