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The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Chung-Ang University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01291979
First received: February 8, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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

A total of 62 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.


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 Tonsillectomy: a Prospective, Randomized, Double-blind, Placebo-controlled Study

Resource links provided by NLM:

U.S. FDA Resources

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

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

    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 Outcome Measures:
  • visual analogue scale 12 hour [ 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, 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 12 hour.


  • visual analogue scale 24hour [ 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, 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 12 hour.


  • Visual analogue scale 48hour [ 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, 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 48 hour.


  • Opioid consumption 4hour [ Time Frame: Post Op 4hour ] [ 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. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg 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 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.

  • Opioid consumption 24hour [ 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 occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg 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 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour 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 occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg 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 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.

  • Opioid consumption 48hour [ 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. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg 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 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured

  • FPB 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 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 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 frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.

  • FPB 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 occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour 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 frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.


Estimated Enrollment: 62
Study Start Date: February 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (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:

  • Tonsillectomy

Exclusion Criteria:

  • mental change
  • allergy to local anesthetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291979

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

Locations
Korea, Republic of
ChungAng University Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: SeongDeok Kim, M.D. & Ph.D.     +82-2-6299-2571     ksdeok@cau.ac.kr    
Principal Investigator: Hyun Kang, Ph.D.            
Sub-Investigator: Kyung Soo Kim, Ph.D.            
Sponsors and Collaborators
Chung-Ang University Hospital
Investigators
Study Chair: Hyun Kang, Ph.D. Chungang University Hospital
Principal Investigator: KyungSoo Kim, Ph.D. Chungang University Hospital
  More Information

No publications provided

Responsible Party: Kyung Soo Kim, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT01291979     History of Changes
Other Study ID Numbers: ChungAngUH1
Study First Received: February 8, 2011
Last Updated: February 8, 2011
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013