The Effect of Ketamine Infusion on Lumbar Surgery

May 29, 2014 updated by: Cholhee Park, Yonsei University

The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Kyung Hyun Kim, MD
          • Phone Number: 82-02-2019-3401
          • Email: NSKHK@yuhs.ac
        • Contact:
          • Cholhee Park, MD
          • Phone Number: 82-02-2019-6079
          • Email: chairp@yuhs.ac
        • Sub-Investigator:
          • Cholhee Park, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Huons ketamine hch injection
Placebo Comparator: Placebo
normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analog Scale
Time Frame: 1 day before lumbar surgery
VAS score in 1 day before lumbar surgery
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
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
3 month after lumbar surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Time Frame: 1 day before lumbar surgery
LANSS score in 1 day before lumbar surgery
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
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
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
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
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
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
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
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
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
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
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
3 month after lumbar surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Kyung Hyun Kim, MD, Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

May 25, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 29, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2014-0062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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