The Effect of Ketamine Infusion on Lumbar Surgery

Phase 4

• Conditions: Chronic Low Back Pain
• Interventions: Drug: Ketamine

• Registration Number: NCT02154438
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-25
• Study First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03
• Primary Completion: 2015-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine	Ketamine	ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation

Primary Outcome Measures

Name	Time	Method
Pain Scores on the Visual Analog Scale	3 month after lumbar surgery	VAS score in 3 month after lumbar surgery

Secondary Outcome Measures

Name	Time	Method
neuropathic pain scale (NPS) score	3 month after lumbar surgery	NPS score in 3 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score	3 month after lumbar surgery	WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score	3 month after lumbar surgery	LANSS score in 3 month after lumbar surgery
Oswestry disability index (ODI) score	3 month after lumbar surgery	ODI score in 3 month after lumbar surgery

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of