Intravenous Lidocaine for Effective Pain Relief After Posterior Lumbar Spinal Fusion: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Intravenous lidocaine injection
- Conditions
- Postoperative Pain
- Sponsor
- Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Postopeartive pain measured using Visual analogue scale at postoperative 4hour
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Hyun Kang
Assistant professor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Eligibility Criteria
Inclusion Criteria
- •1-level posterior lumbar fusion
Exclusion Criteria
- •mental change
- •allergy to local anesthetics
- •chronic analgesics user
Arms & Interventions
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.
Intervention: Intravenous lidocaine injection
Placebo control group
Patients in Group C (placebo control group) received normal saline intravenous injection
Intervention: Intravenous normal saline injection
Outcomes
Primary Outcomes
Postopeartive pain measured using Visual analogue scale at postoperative 4hour
Time Frame: post op 4hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.
Secondary Outcomes
- visual analogue scale 12 hour(Post op 12 hour)
- visual analogue scale 24hour(Post op 24 hour)
- Visual analogue scale 48hour(Post Op 48hour)
- Opioid consumption 4hour(Post Op 4hour)
- Opioid consumption 24hour(Post op 24 hour)
- Opioid consumption 12 hour(Post Op 12 hour)
- Opioid consumption 48hour(Post Op 48 hour)
- FPB 4 hour(Post Op 4 hour)
- FPB 12 hour(post op 12 hour)
- FPB 24 hour(Post Op 24 hour)
- FPB 48 hour(Post Op 48 hour)