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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

Tracking Information
First Submitted Date  ICMJE January 22, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date November 27, 2017
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
numerical rating scale (NRS), pain score. [ Time Frame: Postoperative 3 months ]
Postoperative numerical rating scale (NRS), pain score.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
Postoperative opioid consumption. [ Time Frame: Postoperative 24 h ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
  • opioid consumption. [ Time Frame: Postoperative 24 h ]
    Postoperative opioid consumption.
  • Serum cortisol. [ Time Frame: Postoperative 24 h ]
    Serum cortisol level.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
Serum cortisol level. [ Time Frame: Immediately Postoperative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion
Official Title  ICMJE Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Lidocaine group
    Patients will receive lidocaine infusion.
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Control group
    Patients will receive 0.9% Sodium-chloride infusion infusion
    Intervention: Drug: 0.9% Sodium-chloride
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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030560
Other Study ID Numbers  ICMJE IRB0000871239
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abdelrady S Ibrahim, MD, Assiut University
Study Sponsor  ICMJE Abdelrady S Ibrahim, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed G Abdelraheem, MD Assiut University
PRS Account Assiut University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP