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The Effect of Ketamine Infusion on Lumbar Surgery

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ClinicalTrials.gov Identifier: NCT02154438
Recruitment Status : Unknown
Verified May 2014 by Cholhee Park, Yonsei University.
Recruitment status was:  Recruiting
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Cholhee Park, Yonsei University

Tracking Information
First Submitted Date  ICMJE May 25, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • Pain Scores on the Visual Analog Scale [ Time Frame: 1 day before lumbar surgery ]
    VAS score in 1 day before lumbar surgery
  • Pain Scores on the Visual Analog Scale [ Time Frame: 1 month after lumbar surgery ]
    VAS score in 1 month after lumbar surgery
  • Pain Scores on the Visual Analog Scale [ Time Frame: 3 month after lumbar surgery ]
    VAS score in 3 month after lumbar surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 1 day before lumbar surgery ]
    LANSS score in 1 day before lumbar surgery
  • Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 1 month after lumbar surgery ]
    LANSS score in 1 month after lumbar surgery
  • Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 3 month after lumbar surgery ]
    LANSS score in 3 month after lumbar surgery
  • neuropathic pain scale (NPS) score [ Time Frame: 1 day before lumbar surgery ]
    NPS score in 1 day before lumbar surgery
  • neuropathic pain scale (NPS) score [ Time Frame: 1 month after lumbar surgery ]
    NPS score in 1 month after lumbar surgery
  • neuropathic pain scale (NPS) score [ Time Frame: 3 month after lumbar surgery ]
    NPS score in 3 month after lumbar surgery
  • Oswestry disability index (ODI) score [ Time Frame: 1 day before lumbar surgery ]
    ODI score in 1 day before lumbar surgery
  • Oswestry disability index (ODI) score [ Time Frame: 1 month after lumbar surgery ]
    ODI score in 1 month after lumbar surgery
  • Oswestry disability index (ODI) score [ Time Frame: 3 month after lumbar surgery ]
    ODI score in 3 month after lumbar surgery
  • WHO Quality of Life (WHOQOL-BREF) score [ Time Frame: 1 day before lumbar surgery ]
    WHOQOL-BREF score in 1 day before lumbar surgery
  • WHO Quality of Life (WHOQOL-BREF) score [ Time Frame: 1 month after lumbar surgery ]
    WHOQOL-BREF score in 1 month after lumbar surgery
  • WHO Quality of Life (WHOQOL-BREF) score [ Time Frame: 3 month after lumbar surgery ]
    WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine Infusion on Lumbar Surgery
Official Title  ICMJE The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery
Brief Summary The purpose of this study is to evaluate the effect of ketamine infusion for reduction of neuropathic pain and improvement of quality of life after lumbar surgery.
Detailed Description

Neuropathic pain defined as 'pain caused by a lesion or disease of the somatosensory system'. Neuropathic pain is 20 - 35% of low back pain.

Ketamine is categorized as N-methyl D-aspartate receptor antagonist. Ketamine has an analgesic effect in low dose and anesthetic effect in relative high dose. Also, ketamine is used in chronic neuropathic pain as postherpetic neuralgia., phantom pain, central neuropathic pain, complex regional pain syndrome, ischemic pain.

In this study, ketamine will be infused during lumbar surgery in randomized, double-blind and double-blind parallel group control trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE Drug: Ketamine
ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation
Other Name: Huons ketamine hch injection
Study Arms  ICMJE
  • Experimental: ketamine
    ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2014)		 56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergoing lumbar spine surgery due to back pain patients
  • American Physical Status Classification I or II

Exclusion Criteria:

  • less than 3 month of back pain
  • past history of operation at lumbar area
  • past history of glucoma, drug abuse, alcohol abuse
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02154438
Other Study ID Numbers  ICMJE 3-2014-0062
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cholhee Park, Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung Hyun Kim, MD Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital
PRS Account Yonsei University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP