The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
Information source: Chung-Ang University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Intravenous lidocaine injection (Drug); Intravenous normal saline injection (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Chung-Ang University Hospital Official(s) and/or principal investigator(s):
Hyun Kang, Ph.D.,, Study Chair, Affiliation: Chung-Ang University Hospital
Young-Baeg Kim, Ph.D., Study Director, Affiliation: Chung-Ang University Hospital
Summary
This prospective randomized study aims to evaluate the effectiveness of intravenous
lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar
fusion.
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.
Clinical Details
Official title: Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Postopeartive pain measured using Visual analogue scale at postoperative 4hour
Secondary outcome: visual analogue scale 12 hourvisual analogue scale 24hour Visual analogue scale 48hour Opioid consumption 4hour Opioid consumption 24hour Opioid consumption 12 hour Opioid consumption 48hour FPB 4 hour FPB 12 hour FPB 24 hour FPB 48 hour
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 1-level posterior lumbar fusion
Exclusion Criteria:
- mental change
- allergy to local anesthetics
- chronic analgesics user
Locations and Contacts
ChungAng University, Seoul, Korea, Republic of
Additional Information
Starting date: March 2011
Last updated: August 1, 2013
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