Neuropathic PainNCT06297915
Infusion Treatments of Chronic Peripheral Neuropathic Pain
An observational study of Neuropathic Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Ketamine and Lidocain
- Type of treatment
- Injection or infusion
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2022to 1 Aug 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: For the retrospectively designed study, data (electronic database program of the hospital and files) of the patients admitted to the algology clinic with neuropathic pain symptoms between January 2021 and May 2021 were evaluated.
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This study, it was aimed to evaluate and compare the efficacy of intravenous infusion of ketamine and lidocaine, which have been known and used in pain management and which have recently increased interest in the treatment of peripheric neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- Ketamine, Lidocain
- Keywords
- Lidocaine, Ketamine, Pain measurement, scale
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Group K
Ketamine infusion was administered at 1 mg/kg (in 1 hour)
LidocainDrug
Also called Group L
Lidocaine infusion was administered at 3 mg/kg (in 1 hour)
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Scale
Neuropathic Pain 4 Questions (DN4)
Measured: 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.
Pain Rating Scale
Numeric Rating Scale
Measured: 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''
Secondary outcomes (1)
Quality of Life Scale
Short form-12 (SF-12)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start17 May 2022
- Primary completion10 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Yavuz, Hacettepe University
- Investigators
- Gokhan Sucu, MD, Study chair, HACETTEPE UNIVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297915
- Sponsor's protocol ID
- 2022/08-45
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23432384van 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.
PubMed 26684648Shteamer 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.
PubMed 31613180Jendoubi 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.
PubMed 28442956Sucu MG, Yavuz Mollavelioglu T, Akyuz Yildirim A, Celebi N. Short- and Midterm Analgesic Outcomes of Ketamine Versus Lidocaine Infusion in Chronic Peripheral Neuropathic Pain: A Retrospective Study. Pain Res Manag. 2026;2026(1):e7897619. doi: 10.1155/prm/7897619.
PubMed 42676240
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Comparison of the Effectiveness of Ketamine and Lidocaine Infusion in Peripheral Neuropathic Pain: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06297915
- Acronym / sponsor ID
- 2022/08-45
- Conditions
- Neuropathic Pain
- Keywords
- Lidocaine, Ketamine, Pain measurement, scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 7 Mar 2024 (actual)
- 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.
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.
Detailed description
This study, it was aimed to evaluate and compare the efficacy of intravenous infusion of ketamine and lidocaine, which have been known and used in pain management and which have recently increased interest in the treatment of peripheric neuropathic pain.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For the retrospectively designed study, data (electronic database program of the hospital and files) of the patients admitted to the algology clinic with neuropathic pain symptoms between January 2021 and May 2021 were evaluated.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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: Group KKetamine infusion was administered at 1 mg/kg (in 1 hour) | Drug | – |
| LidocainAlso: Group LLidocaine infusion was administered at 3 mg/kg (in 1 hour) | Drug | – |
Primary outcome
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.
Neuropathic Pain 4 Questions (DN4)
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''
Numeric Rating Scale
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 23432384Niesters 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.
- Background: PubMed 26684648van 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.
- Background: PubMed 31613180Shteamer 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.
- Background: PubMed 28442956Jendoubi 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.
- Derived from this study: PubMed 42676240Sucu MG, Yavuz Mollavelioglu T, Akyuz Yildirim A, Celebi N. Short- and Midterm Analgesic Outcomes of Ketamine Versus Lidocaine Infusion in Chronic Peripheral Neuropathic Pain: A Retrospective Study. Pain Res Manag. 2026;2026(1):e7897619. doi: 10.1155/prm/7897619.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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.
Gokhan Sucu, MD study chair
HACETTEPE UNIVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Mar 2024. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06297915, which also lists 5 linked publications.
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 7 Mar 2024.