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The effect of nefopam on postoperative pain and satisfaction in patients undergoing spinal stenosis surgery: double blind, randomization study

Status Approved

  • First Submitted Date

    2021/03/23

  • Registered Date

    2021/04/07

  • Last Updated Date

    2023/12/01

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006067
    Unique Protocol ID 2019AS0165
    Public/Brief Title The effect of nefopam on postoperative pain and satisfaction in patients undergoing spinal stenosis surgery
    Scientific Title The effect of nefopam on postoperative pain and satisfaction in patients undergoing spinal stenosis surgery: double blind, randomization study
    Acronym nefopam spine
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2019AS0165
    Approval Date 2020-07-07
    Institutional Review Board Name Institutional Review Board on human research of Korea University Ansan Hospital
    Institutional Review Board Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
    Institutional Review Board Telephone 031-412-6514
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Eunsu Choi
    Title M.D.,Ph.D
    Telephone +82-31-412-5294
    Affiliation Korea University Ansan Hospital
    Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
    Contact Person for Public Queries
    Name Eunsu Choi
    Title M.D.,Ph.D
    Telephone +82-31-412-5294
    Affiliation Korea University Ansan Hospital
    Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
    Contact Person for Updating Information
    Name Eunsu Choi
    Title M.D.,Ph.D
    Telephone +82-31-412-5294
    Affiliation Korea University Ansan Hospital
    Address 123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2020-07-07 Actual
    Target Number of Participant 76
    Primary Completion Date 2022-12-13 , Actual
    Study Completion Date 2022-12-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Korea University Ansan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-07-07 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Pharmbio Korea
    Organization Type Pharmaceutical Company
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea University Ansan Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The most representative symptoms of lumbar spinal stenosis (LSS) are paresthesia and pain in the legs along with back pain. It is reported that 30% of patients undergoing surgery have residual symptoms after surgery. In particular, abnormal sensations of the feet or legs remain after surgery, which lowers the patient's satisfaction. Unlike back pain, the sensations of the legs do not respond significantly to the administration of narcotic analgesics, and tend to improve 2 weeks after surgery. The degree of improvement is small, and it is reported in studies. Nefopam (the drug name is acupan) is a kind of non-narcotic analgesic that acts on the central nervous system and acts on the NMDA receptors. This formulation has been shown to be effective in neuropathic pain and in reducing dysesthesia during endoscopic lumbar discectomy. Therefore,we expects that when using Nefopam before the end of anesthesia control postoperative pain , as well as the pain in the lower back, and the degree of paresthesia and pain in the legs, we would like to compare its effects with the group not receiving Nefopam. .
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    At one hour before the end of the surgery ,  Nefopam group receives nefopam 20 mg diluted in 20 ml normal saline and The control group receives 20 ml of normal saline for 20 minutes.
    Number of Arms 2
    Arm 1

    Arm Label

    Nefopam group

    Target Number of Participant

    38

    Arm Type

    Active comparator

    Arm Description

    At one hour before the end of the surgery ,  Nefopam group receives nefopam 20 mg diluted in 20 ml normal saline
    Arm 2

    Arm Label

    The control group

    Target Number of Participant

    38

    Arm Type

    Placebo comparator

    Arm Description

    At one hour before the end of the surgery , The control group receives 20 ml of normal saline for 20 minutes.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M48.06)Spinal stenosis, lumbar region 

    patients diagnosed with spinal stenosis and undergoing spinal surgery.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~75Year

    Description

    1) Patients diagnosed with spinal stenosis due to radicular or enurogenic claudication and scheduled to undergo spinal surgery (decompressionsurgery with or without fusion)
    2) Adult patients aged 20-75
     3) American Society of Anesthesiology Physical Classification 1,2 patients
    4) Patients with informed consent
    Exclusion Criteria
    ) Patient with  lumbar disc herniation or other spinal disorders
    2)Patient with  polyneuropathy, or arteriosclerosis obliterans
    3)Patient with severe pain or disability in other joints
    4)Patient with a psychiatric illness
    5) Patient with peripheral vascular disease
    6) Patient with a serious disease that may affect systemic condition, including cancer or cardiopulmonary disease
    7) Patients sensitive to study drug 
    8) Patients with epilepsy or convulsions.
     9) Patients taking irreversible monoamine oxidase inhibitors
    8) Patients with a history of myocardial infarction
    9) Patients with angle-closure glaucoma
    10) Patients with urinary retention or urethral and prostate disorders
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    severity  of paresthesia or abnormal sensation (Visual Analogue Scale)
    Timepoint
    every 6 hours, 12 hours, 24 hours, 36 hours after the end of anesthesia
    Secondary Outcome(s) 1
    Outcome
    severity of back pain (Visual Analogue Scale)
    Timepoint
    every 6 hours, 12 hours, 24 hours, 36 hours after the end of anesthesia
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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