Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion (Lidocaine)
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|ClinicalTrials.gov Identifier: NCT03030560|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Lidocaine Drug: 0.9% Sodium-chloride||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Masking Description:||Double Blind|
|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|
Active Comparator: Lidocaine group
Patients will receive lidocaine infusion.
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
- numerical rating scale (NRS), pain score. [ Time Frame: Postoperative 3 months ]Postoperative numerical rating scale (NRS), pain score.
- opioid consumption. [ Time Frame: Postoperative 24 h ]Postoperative opioid consumption.
- Serum cortisol. [ Time Frame: Postoperative 24 h ]Serum cortisol level.
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
|Assiut university faculty of medicine|
|Principal Investigator:||Mohamed G Abdelraheem, MD||Assiut University|