The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Chung-Ang University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyun Kang, Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01608360
First received: May 26, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy.

A total 56 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 normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.


Condition Intervention Phase
Postoperative Pain
Drug: Intravenous lidocaine injection
Drug: Intravenous normal saline injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine for Effective Pain Relief After Thyroidectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Chung-Ang University Hospital:

Primary Outcome Measures:
  • Postoperative pain measured using Visual analogue scale at postoperative 2hour [ Time Frame: post op 2hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 2hour.



Secondary Outcome Measures:
  • visual analogue scale 4hour [ Time Frame: post op 4 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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.


  • visual analogue scale 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 8hour.


  • Visual analogue scale 12hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 12hour.


  • visual analogue scale 24hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 24hour.


  • visual analogue scale 48 hour [ Time Frame: Post op 48hour ] [ Designated as safety issue: No ]

    Patients will be assessed for pain using a visual analogue pain scale(VAS). It is usually a horizontal line, 100mm 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 ont the line the 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 48hour.


  • Opioid consumption 2hour [ Time Frame: post op 2hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 2hour will be measured.

  • Opioid consumption 4 hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 4hour will be measured

  • Opioid consumption 8hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 8hour will be measured

  • Opioid consumption 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 12hour will be measured

  • Opioid consumption 24 hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 24hour will be measured

  • Opioid consumption 48 hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occured. In the case of persistent pain greater than a visual analogue scale(VAS) pain score of 30mm, and additional 50㎍ of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30mm. And sum of delivery from PCA system and and additional opioid fom immediately after operation to post op 48hour will be measured

  • FPB 2hour [ Time Frame: Post op 2 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 2 hour will be measured.

  • FPB 4hour [ Time Frame: Post op 4 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.

  • FPB 8 hour [ Time Frame: Post op 8 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 8 hour will be measured.

  • FPB 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 12 hour will be measured.

  • FPB 24hour [ Time Frame: Post op 24hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 24 hour will be measured.

  • FPB 48 hour [ Time Frame: Post op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 48 hour will be measured.


Estimated Enrollment: 56
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: 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.
Other Name: IV lidocaine
Placebo Comparator: Placebo control group
Patients in Group C (placebo control group) received normal saline intravenous injection
Drug: Intravenous normal saline injection
The patients in Group C (placebo control group) received normal saline intravenous injection
Other Name: IV saline

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total thyroidectomy

Exclusion Criteria:

  • mental change
  • allergy to local anesthetics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608360

Contacts
Contact: Hyun Kang, Ph.D 82-2-6299-2571 roman00@naver.com

Locations
Korea, Republic of
ChungAng University Recruiting
Seoul, Korea, Republic of
Contact: SeongDeok Kim, M.D. & Ph.D.    82-2-6299-2571    ksdeok@cau.ac.kr   
Principal Investigator: Hyun Kang, Ph.D.         
Sub-Investigator: Eun Jin Ahn         
Sponsors and Collaborators
Chung-Ang University Hospital
Investigators
Study Chair: Hyun Kang, Ph.D Chungang University Hospital
Principal Investigator: Eun Jin Ahn Chungang University Hospital
  More Information

No publications provided

Responsible Party: Hyun Kang, Assistant professor, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT01608360     History of Changes
Other Study ID Numbers: ChungAngUH3
Study First Received: May 26, 2012
Last Updated: March 17, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Chung-Ang University Hospital:
Pain
Lidocaine
Intravenous
Thyroidectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014