The Effect of Ketamine Infusion on Lumbar Surgery

NCT ID: NCT02154438

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ketamine

ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation

Placebo

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Ketamine

ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation

Intervention Type DRUG

Other Intervention Names

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Huons ketamine hch injection

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Cholhee Park

Clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Hyun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital

Locations

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Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Hyun Kim, MD

Role: CONTACT

82-02-2019-3401

Cholhee Park, MD

Role: CONTACT

82-02-2019-6079

Facility Contacts

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Kyung Hyun Kim, MD

Role: primary

82-02-2019-3401

Cholhee Park, MD

Role: backup

82-02-2019-6079

Other Identifiers

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3-2014-0062

Identifier Type: -

Identifier Source: org_study_id

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