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The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Intravenous lidocaine injection
Intravenous normal saline injection
Sponsored by
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Lidocaine, Intravenous, Thyroidectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Total thyroidectomy

Exclusion Criteria:

  • mental change
  • allergy to local anesthetics

Sites / Locations

  • ChungAng UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intravenous lidocaine injection group

Placebo control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Postoperative pain measured using Visual analogue scale at postoperative 2hour
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
May 26, 2012
Last Updated
March 17, 2014
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01608360
Brief Title
The Effect of Intravenous Lidocaine on Pain After Thyroidectomy
Official Title
Intravenous Lidocaine for Effective Pain Relief After Thyroidectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pain, Lidocaine, Intravenous, Thyroidectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous lidocaine injection group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
Patients in Group C (placebo control group) received normal saline intravenous injection
Intervention Type
Drug
Intervention Name(s)
Intravenous lidocaine injection
Other Intervention Name(s)
IV lidocaine
Intervention Description
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 Type
Drug
Intervention Name(s)
Intravenous normal saline injection
Other Intervention Name(s)
IV saline
Intervention Description
The patients in Group C (placebo control group) received normal saline intravenous injection
Primary Outcome Measure Information:
Title
Postoperative pain measured using Visual analogue scale at postoperative 2hour
Description
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.
Time Frame
post op 2hour
Secondary Outcome Measure Information:
Title
visual analogue scale 4hour
Description
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.
Time Frame
post op 4 hour
Title
visual analogue scale 8 hour
Description
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.
Time Frame
Post op 8 hour
Title
Visual analogue scale 12hour
Description
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.
Time Frame
Post op 12 hour
Title
visual analogue scale 24hour
Description
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.
Time Frame
Post op 24 hour
Title
visual analogue scale 48 hour
Description
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.
Time Frame
Post op 48hour
Title
Opioid consumption 2hour
Description
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.
Time Frame
post op 2hour
Title
Opioid consumption 4 hour
Description
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
Time Frame
Post op 4 hour
Title
Opioid consumption 8hour
Description
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
Time Frame
Post op 8 hour
Title
Opioid consumption 12 hour
Description
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
Time Frame
Post op 12 hour
Title
Opioid consumption 24 hour
Description
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
Time Frame
Post op 24 hour
Title
Opioid consumption 48 hour
Description
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
Time Frame
Post op 48 hour
Title
FPB 2hour
Description
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.
Time Frame
Post op 2 hour
Title
FPB 4hour
Description
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.
Time Frame
Post op 4 hour
Title
FPB 8 hour
Description
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.
Time Frame
Post op 8 hour
Title
FPB 12 hour
Description
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.
Time Frame
Post op 12 hour
Title
FPB 24hour
Description
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.
Time Frame
Post op 24hour
Title
FPB 48 hour
Description
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.
Time Frame
Post op 48 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Total thyroidectomy Exclusion Criteria: mental change allergy to local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Kang, Ph.D
Phone
82-2-6299-2571
Email
roman00@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kang, Ph.D
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eun Jin Ahn
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChungAng University
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeongDeok Kim, M.D. & Ph.D.
Phone
82-2-6299-2571
Email
ksdeok@cau.ac.kr
First Name & Middle Initial & Last Name & Degree
Hyun Kang, Ph.D.
First Name & Middle Initial & Last Name & Degree
Eun Jin Ahn

12. IPD Sharing Statement

Citations:
PubMed Identifier
27379388
Citation
Choi GJ, Kang H, Ahn EJ, Oh JI, Baek CW, Jung YH, Kim JY. Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. World J Surg. 2016 Dec;40(12):2941-2947. doi: 10.1007/s00268-016-3619-6.
Results Reference
derived

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The Effect of Intravenous Lidocaine on Pain After Thyroidectomy

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