- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06297915
Infusion Treatments of Chronic Peripheral Neuropathic Pain
Evaluation and Comparison of the Effectiveness of Ketamine and Lidocaine Infusion in Peripheral Neuropathic Pain: A Retrospective Study
This study aimed to evaluate and compare the efficacy of ketamine and lidocaine infusion in patients with chronic peripheral neuropathic pain.
Patients who received intravenous ketamine infusion and the other patient group who received intravenous lidocaine infusion were evaluated in the study. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cankaya
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Ankara, Cankaya, Turkey, 06360
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-65 years of age
- Patients with peripheral neuropathic pain (radicular neuropathy, diabetic neuropathy, complex regional pain syndrome type 2, traumatic peripheral nerve injury, trigeminal neuralgia, postherpetic neuralgia)
- Patients who was evaluated by DN4 scores with of ≥4 points
Exclusion Criteria:
- Patients with central nervous system disease .
- Patients with cancer related neuropatic pain.
- Patients with central neuropathic pain patterns.
- Patients with renal, hepatic, cardiovascular, and psychiatric diseases.
- Patients whose treatment could not be completed due to side effects or other reasons.
- Patients who had lost their follow-up .
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropathic Pain Scale
Time Frame: Before treatment at two weeks, two months, and six months after treatment.The 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more outout of ,10 point (severe pain ) is suggestive of neuropathic pain.
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Neuropathic Pain 4 Questions (DN4)
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Before treatment at two weeks, two months, and six months after treatment.The 7 symptoms items are scored by interviewing the patient.The scores are added and a score of 4 or more outout of ,10 point (severe pain ) is suggestive of neuropathic pain.
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Pain Rating Scale
Time Frame: Before treatment at two weeks, two months, and six months after treatment.NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''
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Numeric Rating Scale
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Before treatment at two weeks, two months, and six months after treatment.NRS in which individuals rate their pain on an ten-point numerical scale. Zero:''no pain at all' ten-point ''severe pain''
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Scale
Time Frame: Before treatment at two weeks, two months, and six months after treatment.12-question survey PCS and the MCS Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
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Short form-12 (SF-12)
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Before treatment at two weeks, two months, and six months after treatment.12-question survey PCS and the MCS Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gokhan Sucu, MD, Hacettepe University
Publications and helpful links
General Publications
- Jendoubi A, Naceur IB, Bouzouita A, Trifa M, Ghedira S, Chebil M, Houissa M. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study. Saudi J Anaesth. 2017 Apr-Jun;11(2):177-184. doi: 10.4103/1658-354X.203027.
- van der Wal SE, van den Heuvel SA, Radema SA, van Berkum BF, Vaneker M, Steegers MA, Scheffer GJ, Vissers KC. The in vitro mechanisms and in vivo efficacy of intravenous lidocaine on the neuroinflammatory response in acute and chronic pain. Eur J Pain. 2016 May;20(5):655-74. doi: 10.1002/ejp.794. Epub 2015 Dec 18.
- Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br J Clin Pharmacol. 2014 Feb;77(2):357-67. doi: 10.1111/bcp.12094.
- Shteamer JW, Callaway MA, Patel P, Singh V. How effective is ketamine in the management of chronic neuropathic pain? Pain Manag. 2019 Nov;9(6):517-519. doi: 10.2217/pmt-2019-0032. Epub 2019 Oct 15. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- 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
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Ketamine
- Lidocaine
Other Study ID Numbers
- 2022/08-45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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