Clinical trial NCT02154438: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Low Back Pain
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 1 day before lumbar surgery
measure: Pain Scores on the Visual Analog Scale
timeFrame: 1 month after lumbar surgery
measure: Pain Scores on the Visual Analog Scale
timeFrame: 3 month after lumbar surgery
Secondary outcomes:
measure: Leeds assessment of neuropathic symptoms and signs (LANSS) score
timeFrame: 1 day before lumbar surgery
measure: Leeds assessment of neuropathic symptoms and signs (LANSS) score
timeFrame: 1 month after lumbar surgery
measure: Leeds assessment of neuropathic symptoms and signs (LANSS) score
timeFrame: 3 month after lumbar surgery
measure: neuropathic pain scale (NPS) score
timeFrame: 1 day before lumbar surgery
measure: neuropathic pain scale (NPS) score
timeFrame: 1 month after lumbar surgery
measure: neuropathic pain scale (NPS) score
timeFrame: 3 month after lumbar surgery
measure: Oswestry disability index (ODI) score
timeFrame: 1 day before lumbar surgery
measure: Oswestry disability index (ODI) score
timeFrame: 1 month after lumbar surgery
measure: Oswestry disability index (ODI) score
timeFrame: 3 month after lumbar surgery
measure: WHO Quality of Life (WHOQOL-BREF) score
timeFrame: 1 day before lumbar surgery
measure: WHO Quality of Life (WHOQOL-BREF) score
timeFrame: 1 month after lumbar surgery
measure: WHO Quality of Life (WHOQOL-BREF) score
timeFrame: 3 month after lumbar surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital
name: Kyung Hyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: