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The Effect of Ketamine Infusion on Lumbar Surgery

Primary Purpose

Chronic Low Back Pain

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gangnam Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ketamine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analog Scale
VAS score in 1 day before lumbar surgery
Pain Scores on the Visual Analog Scale
VAS score in 1 month after lumbar surgery
Pain Scores on the Visual Analog Scale
VAS score in 3 month after lumbar surgery

Secondary Outcome Measures

Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 1 day before lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 1 month after lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 3 month after lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 1 day before lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 1 month after lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 3 month after lumbar surgery
Oswestry disability index (ODI) score
ODI score in 1 day before lumbar surgery
Oswestry disability index (ODI) score
ODI score in 1 month after lumbar surgery
Oswestry disability index (ODI) score
ODI score in 3 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
WHOQOL-BREF score in 1 day before lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
WHOQOL-BREF score in 1 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery

Full Information

First Posted
May 25, 2014
Last Updated
May 29, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02154438
Brief Title
The Effect of Ketamine Infusion on Lumbar Surgery
Official Title
The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketamine
Arm Type
Experimental
Arm Description
ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Huons ketamine hch injection
Intervention Description
ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
VAS score in 1 day before lumbar surgery
Time Frame
1 day before lumbar surgery
Title
Pain Scores on the Visual Analog Scale
Description
VAS score in 1 month after lumbar surgery
Time Frame
1 month after lumbar surgery
Title
Pain Scores on the Visual Analog Scale
Description
VAS score in 3 month after lumbar surgery
Time Frame
3 month after lumbar surgery
Secondary Outcome Measure Information:
Title
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Description
LANSS score in 1 day before lumbar surgery
Time Frame
1 day before lumbar surgery
Title
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Description
LANSS score in 1 month after lumbar surgery
Time Frame
1 month after lumbar surgery
Title
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Description
LANSS score in 3 month after lumbar surgery
Time Frame
3 month after lumbar surgery
Title
neuropathic pain scale (NPS) score
Description
NPS score in 1 day before lumbar surgery
Time Frame
1 day before lumbar surgery
Title
neuropathic pain scale (NPS) score
Description
NPS score in 1 month after lumbar surgery
Time Frame
1 month after lumbar surgery
Title
neuropathic pain scale (NPS) score
Description
NPS score in 3 month after lumbar surgery
Time Frame
3 month after lumbar surgery
Title
Oswestry disability index (ODI) score
Description
ODI score in 1 day before lumbar surgery
Time Frame
1 day before lumbar surgery
Title
Oswestry disability index (ODI) score
Description
ODI score in 1 month after lumbar surgery
Time Frame
1 month after lumbar surgery
Title
Oswestry disability index (ODI) score
Description
ODI score in 3 month after lumbar surgery
Time Frame
3 month after lumbar surgery
Title
WHO Quality of Life (WHOQOL-BREF) score
Description
WHOQOL-BREF score in 1 day before lumbar surgery
Time Frame
1 day before lumbar surgery
Title
WHO Quality of Life (WHOQOL-BREF) score
Description
WHOQOL-BREF score in 1 month after lumbar surgery
Time Frame
1 month after lumbar surgery
Title
WHO Quality of Life (WHOQOL-BREF) score
Description
WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery
Time Frame
3 month after lumbar surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Hyun Kim, MD
Phone
82-02-2019-3401
Email
NSKHK@yuhs.ac
First Name & Middle Initial & Last Name or Official Title & Degree
Cholhee Park, MD
Phone
82-02-2019-6079
Email
chairp@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Hyun Kim, MD
Organizational Affiliation
Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung Hyun Kim, MD
Phone
82-02-2019-3401
Email
NSKHK@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Cholhee Park, MD
Phone
82-02-2019-6079
Email
chairp@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Cholhee Park, MD

12. IPD Sharing Statement

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The Effect of Ketamine Infusion on Lumbar Surgery

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