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

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: Chronic Low Back Pain
• Intervention / Treatment: Drug: Ketamine

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

• Study Contact: Name: Kyung Hyun Kim, MD; Phone Number: 82-02-2019-3401; Email: NSKHK@yuhs.ac
• Study Contact Backup: Name: Cholhee Park, MD; Phone Number: 82-02-2019-6079; Email: chairp@yuhs.ac

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

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

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: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 3-2014-0062