Infusion Treatments of Chronic Peripheral Neuropathic Pain

NCT06297915 | Completed

• 1 other identifier: 2022/08-45
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Keywords

Lidocaine; Ketamine; Pain measurement, scale

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (1)

• Quality of Life Scale

  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.

Interventions

Ketamine DRUG

Ketamine infusion was administered at 1 mg/kg (in 1 hour)

Also known as: Group K

Lidocain DRUG

Lidocaine infusion was administered at 3 mg/kg (in 1 hour)

Also known as: Group L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Cankaya, 06360, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 23432384 BACKGROUND

• 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.

  PMID: 26684648 BACKGROUND

• 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.

  PMID: 31613180 BACKGROUND

• 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.

  PMID: 28442956 BACKGROUND

MeSH Terms

Conditions

Neuralgia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gokhan Sucu, MD

  HACETTEPE UNIVERSİTY

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: May 17, 2022
• Primary Completion: May 10, 2023
• Study Completion: August 1, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

TU (1)