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NCT02154438 Clinical Trial

The Effect of Ketamine Infusion on Lumbar Surgery

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02154438
Other study ID # 3-2014-0062
Secondary ID
Status Recruiting
Phase Phase 4
First received May 25, 2014
Last updated May 29, 2014
Start date May 2014
Est. completion date April 2015

Study information
Verified date May 2014
Source Yonsei University
Contact Kyung Hyun Kim, MD
Phone 82-02-2019-3401
Email NSKHK@yuhs.ac
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ketamine
ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation

Locations
Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Scores on the Visual Analog Scale VAS score in 1 day before lumbar surgery 1 day before lumbar surgery No
Primary Pain Scores on the Visual Analog Scale VAS score in 1 month after lumbar surgery 1 month after lumbar surgery No
Primary Pain Scores on the Visual Analog Scale VAS score in 3 month after lumbar surgery 3 month after lumbar surgery No
Secondary Leeds assessment of neuropathic symptoms and signs (LANSS) score LANSS score in 1 day before lumbar surgery 1 day before lumbar surgery No
Secondary Leeds assessment of neuropathic symptoms and signs (LANSS) score LANSS score in 1 month after lumbar surgery 1 month after lumbar surgery No
Secondary Leeds assessment of neuropathic symptoms and signs (LANSS) score LANSS score in 3 month after lumbar surgery 3 month after lumbar surgery No
Secondary neuropathic pain scale (NPS) score NPS score in 1 day before lumbar surgery 1 day before lumbar surgery No
Secondary neuropathic pain scale (NPS) score NPS score in 1 month after lumbar surgery 1 month after lumbar surgery No
Secondary neuropathic pain scale (NPS) score NPS score in 3 month after lumbar surgery 3 month after lumbar surgery No
Secondary Oswestry disability index (ODI) score ODI score in 1 day before lumbar surgery 1 day before lumbar surgery No
Secondary Oswestry disability index (ODI) score ODI score in 1 month after lumbar surgery 1 month after lumbar surgery No
Secondary Oswestry disability index (ODI) score ODI score in 3 month after lumbar surgery 3 month after lumbar surgery No
Secondary WHO Quality of Life (WHOQOL-BREF) score WHOQOL-BREF score in 1 day before lumbar surgery 1 day before lumbar surgery No
Secondary WHO Quality of Life (WHOQOL-BREF) score WHOQOL-BREF score in 1 month after lumbar surgery 1 month after lumbar surgery No
Secondary WHO Quality of Life (WHOQOL-BREF) score WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery 3 month after lumbar surgery No
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