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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

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Ketamine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery
Study Start Date : May 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine
ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
Drug: Ketamine
ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation
Other Name: Huons ketamine hch injection

Placebo Comparator: Placebo
normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation



Primary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: 1 day before lumbar surgery ]
    VAS score in 1 day before lumbar surgery

  2. Pain Scores on the Visual Analog Scale [ Time Frame: 1 month after lumbar surgery ]
    VAS score in 1 month after lumbar surgery

  3. Pain Scores on the Visual Analog Scale [ Time Frame: 3 month after lumbar surgery ]
    VAS score in 3 month after lumbar surgery


Secondary Outcome Measures :
  1. Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 1 day before lumbar surgery ]
    LANSS score in 1 day before lumbar surgery

  2. Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 1 month after lumbar surgery ]
    LANSS score in 1 month after lumbar surgery

  3. Leeds assessment of neuropathic symptoms and signs (LANSS) score [ Time Frame: 3 month after lumbar surgery ]
    LANSS score in 3 month after lumbar surgery

  4. neuropathic pain scale (NPS) score [ Time Frame: 1 day before lumbar surgery ]
    NPS score in 1 day before lumbar surgery

  5. neuropathic pain scale (NPS) score [ Time Frame: 1 month after lumbar surgery ]
    NPS score in 1 month after lumbar surgery

  6. neuropathic pain scale (NPS) score [ Time Frame: 3 month after lumbar surgery ]
    NPS score in 3 month after lumbar surgery

  7. Oswestry disability index (ODI) score [ Time Frame: 1 day before lumbar surgery ]
    ODI score in 1 day before lumbar surgery

  8. Oswestry disability index (ODI) score [ Time Frame: 1 month after lumbar surgery ]
    ODI score in 1 month after lumbar surgery

  9. Oswestry disability index (ODI) score [ Time Frame: 3 month after lumbar surgery ]
    ODI score in 3 month after lumbar surgery

  10. WHO Quality of Life (WHOQOL-BREF) score [ Time Frame: 1 day before lumbar surgery ]
    WHOQOL-BREF score in 1 day before lumbar surgery

  11. WHO Quality of Life (WHOQOL-BREF) score [ Time Frame: 1 month after lumbar surgery ]
    WHOQOL-BREF score in 1 month after lumbar surgery

  12. 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



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02154438


Contacts
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Contact: Kyung Hyun Kim, MD 82-02-2019-3401 NSKHK@yuhs.ac
Contact: Cholhee Park, MD 82-02-2019-6079 chairp@yuhs.ac

Locations
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Korea, Republic of
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Kyung Hyun Kim, MD    82-02-2019-3401    NSKHK@yuhs.ac   
Contact: Cholhee Park, MD    82-02-2019-6079    chairp@yuhs.ac   
Sub-Investigator: Cholhee Park, MD         
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Kyung Hyun Kim, MD Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital

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Responsible Party: Cholhee Park, Clinical assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02154438     History of Changes
Other Study ID Numbers: 3-2014-0062
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Ketamine
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action