Infusion Treatments of Chronic Peripheral Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

Evaluation and Comparison of the Effectiveness of Ketamine and Lidocaine Infusion in Peripheral Neuropathic Pain: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06297915
• Other study ID #: 2022/08-45
• Status: Completed
• Start date: May 17, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Pain scores and quality of life were assessed with scales before treatment at two weeks, two months, and six months after treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 1, 2023
• Est. primary completion date: May 10, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Ketamine
Ketamine infusion was administered at 1 mg/kg (in 1 hour)
• Lidocain
Lidocaine infusion was administered at 3 mg/kg (in 1 hour)

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic Pain Scale	Neuropathic Pain 4 Questions (DN4)	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.
Primary	Pain Rating Scale	Numeric Rating Scale	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	Quality of Life Scale	Short form-12 (SF-12)	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.