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The Effect of Ketamine Infusion on Lumbar Surgery

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02154438
Enrollment
56
Registered
2014-06-03
Start date
2014-05-31
Completion date
2015-04-30
Last updated
2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

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.

Interventions

DRUGKetamine

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Scores on the Visual Analog Scale1 day before lumbar surgeryVAS score in 1 day before lumbar surgery

Secondary

MeasureTime frameDescription
Leeds assessment of neuropathic symptoms and signs (LANSS) score1 day before lumbar surgeryLANSS score in 1 day before lumbar surgery
neuropathic pain scale (NPS) score1 day before lumbar surgeryNPS score in 1 day before lumbar surgery
Oswestry disability index (ODI) score1 day before lumbar surgeryODI score in 1 day before lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score1 day before lumbar surgeryWHOQOL-BREF score in 1 day before lumbar surgery

Countries

South Korea

Contacts

Primary ContactKyung Hyun Kim, MD
NSKHK@yuhs.ac82-02-2019-3401
Backup ContactCholhee Park, MD
chairp@yuhs.ac82-02-2019-6079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026