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The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.

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ClinicalTrials.gov Identifier: NCT02762656
Recruitment Status : Unknown
Verified May 2016 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
The purpose of this study is to evaluate the effectiveness of perioperative Lidocaine intravenous infusion in reducing postoperative pain for spine surgery patients.

Condition or disease Intervention/treatment Phase
Spinal Diseases Drug: Lidocaine Phase 4

Detailed Description:

Study design: this study used a prospective, randomized, double-blinded, and placebo-controlled clinical trial.

Sixty patients scheduled for a spine surgery will be randomly assigned to two groups. Lidocaine group will receive an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Placebo group will receive the same dosage of saline at the same time. Analgesic requirement will be monitored using patient-controlled Analgesia (PCA protocol: demand dose is 2 mg of morphine, lockout 5 min, maximum dose 15 mg per hour). Forty-eight hours after surgery, we will check the morphine consumption in two groups. Quality of recovery after surgery will be assessed using Q0R15 questionnaire.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
Patients will receive Lidocaine drip during spine surgery
Drug: Lidocaine
Lidocaine drip during surgery

Placebo Comparator: Placebo
Patients will receive placebo during spine surgery
Drug: Lidocaine
Lidocaine drip during surgery




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours postop ]
    Quality of recovery after surgery will be assessed using Q0R15 questionnaire and analgesic requirement will be monitored using PCA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • spine surgery with general anesthesia

Exclusion Criteria:

  • lidocaine allergy
  • hepatic disease
  • dementia or cognitive decline

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): NCT02762656


Contacts
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Contact: Haim Berkenstadt, MD 03-5302754 ext +972 Haim.Berkenstadt@sheba.health.gov.il
Contact: Vladimir Solovyev, MD 054-6800749 ext +972 gaster1313@gmail.com

Locations
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Israel
Sheba Medical Center
Ramat Gan, Israel, 5262100
Sponsors and Collaborators
Sheba Medical Center

Additional Information:
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02762656     History of Changes
Other Study ID Numbers: SHEBA-16-2972-VS-CTIL
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
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