Chronic Low Back PainPhase 4NCT02154438
The Effect of Ketamine Infusion on Lumbar Surgery
A Phase 4 study testing Ketamine in people with Chronic Low Back Pain, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing lumbar spine surgery due to back pain patients
- American Physical Status Classification I or II
Who cannot join
- less than 3 month of back pain
- past history of operation at lumbar area
- past history of glucoma, drug abuse, alcohol abuse
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, 135-720
Kyung Hyun Kim, MD, 82-02-2019-3401, NSKHK@yuhs.ac
Cholhee Park, MD, 82-02-2019-6079, chairp@yuhs.ac
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Huons ketamine hch injection
ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Experimental | ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation Receives: Drug: Ketamine |
| Placebo | Placebo comparator | normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Visual Analog Scale
VAS score in 1 day before lumbar surgery
Measured: 1 day before lumbar surgery
Pain Scores on the Visual Analog Scale
VAS score in 1 month after lumbar surgery
Measured: 1 month after lumbar surgery
Pain Scores on the Visual Analog Scale
VAS score in 3 month after lumbar surgery
Measured: 3 month after lumbar surgery
Secondary outcomes (12)
Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 1 day before lumbar surgery
Measured: 1 day before lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 1 month after lumbar surgery
Measured: 1 month after lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
LANSS score in 3 month after lumbar surgery
Measured: 3 month after lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 1 day before lumbar surgery
Measured: 1 day before lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 1 month after lumbar surgery
Measured: 1 month after lumbar surgery
neuropathic pain scale (NPS) score
NPS score in 3 month after lumbar surgery
Measured: 3 month after lumbar surgery
Oswestry disability index (ODI) score
ODI score in 1 day before lumbar surgery
Measured: 1 day before lumbar surgery
Oswestry disability index (ODI) score
ODI score in 1 month after lumbar surgery
Measured: 1 month after lumbar surgery
Oswestry disability index (ODI) score
ODI score in 3 month after lumbar surgery
Measured: 3 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
WHOQOL-BREF score in 1 day before lumbar surgery
Measured: 1 day before lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
WHOQOL-BREF score in 1 month after lumbar surgery
Measured: 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
Measured: 3 month after lumbar surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cholhee Park, Yonsei University
- Investigators
- Kyung Hyun Kim, MD, Principal investigator, Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154438
- Sponsor's protocol ID
- 3-2014-0062
- Status last verified
- May 2014
- First submitted
- 25 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery
- ClinicalTrials.gov ID
- NCT02154438
- Acronym / sponsor ID
- 3-2014-0062
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine | Experimental | Drug: Ketamineketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation |
| Placebo | Placebo comparator | –normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing lumbar spine surgery due to back pain patients
- American Physical Status Classification I or II
Key exclusion criteria (4 listed)
- less than 3 month of back pain
- past history of operation at lumbar area
- past history of glucoma, drug abuse, alcohol abuse
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Huons ketamine hch injectionketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation | Drug | ketamine |
Primary outcome
Pain Scores on the Visual Analog Scale
Time frame: 1 day before lumbar surgery
VAS score in 1 day before lumbar surgery
Pain Scores on the Visual Analog Scale
Time frame: 1 month after lumbar surgery
VAS score in 1 month after lumbar surgery
Pain Scores on the Visual Analog Scale
Time frame: 3 month after lumbar surgery
VAS score in 3 month after lumbar surgery
12 secondary outcomes
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Time frame: 1 day before lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Time frame: 1 month after lumbar surgery
Leeds assessment of neuropathic symptoms and signs (LANSS) score
Time frame: 3 month after lumbar surgery
neuropathic pain scale (NPS) score
Time frame: 1 day before lumbar surgery
neuropathic pain scale (NPS) score
Time frame: 1 month after lumbar surgery
neuropathic pain scale (NPS) score
Time frame: 3 month after lumbar surgery
Oswestry disability index (ODI) score
Time frame: 1 day before lumbar surgery
Oswestry disability index (ODI) score
Time frame: 1 month after lumbar surgery
Oswestry disability index (ODI) score
Time frame: 3 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
Time frame: 1 day before lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
Time frame: 1 month after lumbar surgery
WHO Quality of Life (WHOQOL-BREF) score
Time frame: 3 month after lumbar surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Hyun Kim, MD principal investigator
Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Chronic Low Back Pain, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Hyun Kim, MD (82-02-2019-3401, NSKHK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores on the Visual Analog Scale (time frame: 1 day before lumbar surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.