The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
NCT ID: NCT01319682
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2011-03-31
2013-02-28
Brief Summary
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A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.
Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intravenous lidocaine injection group
Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Intravenous lidocaine injection
Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Placebo control group
Patients in Group C (placebo control group) received normal saline intravenous injection
Intravenous normal saline injection
The patients in Group C (placebo control group) received normal saline intravenous injection
Interventions
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Intravenous lidocaine injection
Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
Intravenous normal saline injection
The patients in Group C (placebo control group) received normal saline intravenous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* allergy to local anesthetics
* chronic analgesics user
18 Years
85 Years
ALL
No
Sponsors
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Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Responsible Party
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Hyun Kang
Assistant professor
Principal Investigators
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Hyun Kang, Ph.D.,
Role: STUDY_CHAIR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Young-Baeg Kim, Ph.D.
Role: STUDY_DIRECTOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Locations
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ChungAng University
Seoul, , South Korea
Countries
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References
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Kim KT, Cho DC, Sung JK, Kim YB, Kang H, Song KS, Choi GJ. Intraoperative systemic infusion of lidocaine reduces postoperative pain after lumbar surgery: a double-blinded, randomized, placebo-controlled clinical trial. Spine J. 2014 Aug 1;14(8):1559-66. doi: 10.1016/j.spinee.2013.09.031. Epub 2013 Nov 8.
Other Identifiers
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ChungAngUH2
Identifier Type: -
Identifier Source: org_study_id