Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion (Lidocaine)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine
0.9% Sodium-chloride
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
Age > 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation
Exclusion Criteria:
- Previous spinal fusion surgery.
- Morbid obesity (BMI > 40)
- Diagnosis of spinal metastatic cancer
- Allergy to an amide local anesthetic or morphine sulfate
- History of renal dysfunction, liver dysfunction or congestive heart failure
- History of substance abuse disorder.
- Chronic opioid use.
Sites / Locations
- Assiut university faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lidocaine group
Control group
Arm Description
Patients will receive lidocaine infusion.
Patients will receive 0.9% Sodium-chloride infusion infusion
Outcomes
Primary Outcome Measures
numerical rating scale (NRS), pain score.
Postoperative numerical rating scale (NRS), pain score.
Secondary Outcome Measures
opioid consumption.
Postoperative opioid consumption.
Serum cortisol.
Serum cortisol level.
Full Information
NCT ID
NCT03030560
First Posted
January 22, 2017
Last Updated
November 23, 2017
Sponsor
Abdelrady S Ibrahim, MD
1. Study Identification
Unique Protocol Identification Number
NCT03030560
Brief Title
Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion
Acronym
Lidocaine
Official Title
Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdelrady S Ibrahim, MD
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine group
Arm Type
Active Comparator
Arm Description
Patients will receive lidocaine infusion.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive 0.9% Sodium-chloride infusion infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium-chloride
Other Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
numerical rating scale (NRS), pain score.
Description
Postoperative numerical rating scale (NRS), pain score.
Time Frame
Postoperative 3 months
Secondary Outcome Measure Information:
Title
opioid consumption.
Description
Postoperative opioid consumption.
Time Frame
Postoperative 24 h
Title
Serum cortisol.
Description
Serum cortisol level.
Time Frame
Postoperative 24 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal fusion or fixation
Exclusion Criteria:
Previous spinal fusion surgery.
Morbid obesity (BMI > 40)
Diagnosis of spinal metastatic cancer
Allergy to an amide local anesthetic or morphine sulfate
History of renal dysfunction, liver dysfunction or congestive heart failure
History of substance abuse disorder.
Chronic opioid use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed G Abdelraheem, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20682165
Citation
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.
Results Reference
background
Learn more about this trial
Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion
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