NCT01319682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2011

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 2, 2013

Status Verified

March 1, 2011

Enrollment Period

1.9 years

First QC Date

March 21, 2011

Last Update Submit

August 1, 2013

Conditions

Postoperative Pain

Keywords

PainPreemptiveLidocaineIntravenousLumbar fusion

Outcome Measures

Primary Outcomes (1)

  • Postopeartive pain measured using Visual analogue scale at postoperative 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.

    post op 4hour

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

Intravenous lidocaine injection group

ACTIVE COMPARATOR

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.

Drug: Intravenous lidocaine injection

Placebo control group

PLACEBO COMPARATOR

Patients in Group C (placebo control group) received normal saline intravenous injection

Drug: Intravenous normal saline injection

Interventions

Intravenous lidocaine injectionDRUG

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.

Also known as: IV lidocaine
Intravenous lidocaine injection group
Intravenous normal saline injectionDRUG

The patients in Group C (placebo control group) received normal saline intravenous injection

Also known as: IV saline
Placebo control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • level posterior lumbar fusion

You may not qualify if:

  • mental change
  • allergy to local anesthetics
  • chronic analgesics user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChungAng University

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24216403DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

LidocaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hyun Kang, Ph.D.,

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    STUDY CHAIR

  • Young-Baeg Kim, Ph.D.

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 21, 2011

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 2, 2013

Record last verified: 2011-03

Locations

KR(1)