NCT02154438

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

May 25, 2014

Last Update Submit

May 29, 2014

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (12)

  • Leeds assessment of neuropathic symptoms and signs (LANSS) score

    1 day before lumbar surgery

  • Leeds assessment of neuropathic symptoms and signs (LANSS) score

    1 month after lumbar surgery

  • Leeds assessment of neuropathic symptoms and signs (LANSS) score

    3 month after lumbar surgery

  • neuropathic pain scale (NPS) score

    1 day before lumbar surgery

  • neuropathic pain scale (NPS) score

    1 month after lumbar surgery

  • +7 more secondary outcomes

Study Arms (2)

ketamine

EXPERIMENTAL

ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation

Interventions

KetamineDRUG

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

Also known as: Huons ketamine hch injection
ketamine

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing lumbar spine surgery due to back pain patients
  • American Physical Status Classification I or II

You may not qualify if:

  • less than 3 month of back pain
  • past history of operation at lumbar area
  • past history of glucoma, drug abuse, alcohol abuse
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, 135-720, South Korea

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Kyung Hyun Kim, MD

    Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hyun Kim, MD

CONTACT

82-02-2019-3401NSKHK@yuhs.ac

Cholhee Park, MD

CONTACT

82-02-2019-6079chairp@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

May 25, 2014

First Posted

June 3, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations

KR(1)