Topics

Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study

2019-10-14 10:28:33 | BioPortfolio

Summary

As lidocaine and ketamine provide analgesia by acting on different molecular pathways, administering them together may produce synergistic effects, which can allow for using a lower dose of each medication and thereby reducing the corresponding side effects. To the investigator's knowledge, despite the common practice of multimodal analgesia, lidocaine-ketamine infusions have never been studied prospectively in an out of hospital setting to treat neuropathic pain. The aim of the present study is to evaluate the effectiveness of the current routine practice of lidocaine-ketamine infusions conducted at Allevio Pain Management Clinic, a large outpatient community based chronic pain management facility. Lidocaine-ketamine infusions are prescribed to patients that have pain that is considered to be neuropathic for which standard anti-neuropathic medications have been ineffective or poorly tolerated by patients. A prospective longitudinal study.

Description

Study objectives

1. To evaluate effectiveness of lidocaine-ketamine infusions in reducing neuropathic pain, as assessed using the Revised Pain Quality Assessment Scale (PQAS-R) and Short Form Brief Pain Inventory (BPI-SF).

2. To evaluate the effects of lidocaine-ketamine infusions on the measures of Global Improvement and Satisfaction Score, Pain Self-Efficacy Questionnaire (PSEQ), Pain Catastrophic Scale (PCS), Beck Depression Inventory (BDI), and Patient self-reported perceived duration of effect (PSPDE).

3. To assess, analyze, and report adverse events

The study will be conducted per IMMPACT recommendations (17). Multi variable parameters will be captured: pain unpleasantness, physical function, emotional function, global improvement and satisfaction with treatment, adverse events and disposition. Additional instruments will be used in the triage process and follow-up (S-LANSS, PSEQ).

Number of subjects: all eligible consecutive patients accepted for lidocaine-ketamine infusions over period of 6 months.

Patients with multi focal and/or non-dermatomal pain with neuropathic component will be included.

Dosing and infusion orders are completed by one of the physician-investigators prior to patient arrival based on body weight, and modified if required after individual evaluation. Based on published literature and clinical impression, higher doses seem to be more effective and result in longer pain relief. Therefore, subsequent infusion doses will be increased to the maximally tolerated doses (i.e. minimal side effects).

Doses will be calculated using the following:

- Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.

- Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects.

Standard clinic procedure will be followed for completing the infusions and managing side effects. The infusion will be initiated at 360 ml/hour for planned completion in 45 minutes, rate adjusted if side effects develop. Total doses of medication are recorded in the medical record.

Data collection and Management All study tools will be completed by patients online using, or in the clinic RedCap system. RedCap is a mature, secure web application for building and managing online surveys and databases (Vanderbilt University). The system is secured by SSL protocol and data is encrypted. Patients will be contacted via Email with a secure link to RedCap database, or if they would not be able to do it at home research, they can complete the questionnaires with research coordinator's assistant in secure computers at the clinic. Participant will receive reminders about upcoming visits and promoted to complete the follow-up forms. Allevio data protection is also SSL enabled and secured by SHA256, and they are issued by Rapid SSL and purchased through Ceerts4Less.

Study Design

Conditions

Patient With Chronic Neuropathic Pain and Fibromyalgia

Intervention

Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992

Location

Allevio Pain Management Clinic
Toronto
Ontario
Canada
M3B 3S6

Status

Recruiting

Source

Allevio Pain Management Clinic

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-14T10:28:33-0400

Clinical Trials [3090 Associated Clinical Trials listed on BioPortfolio]

Effect of IV Lidocaine Infusions on Pain

Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. St...

Intravenous Lidocaine for Perioperative and Postoperative Analgesia

Postoperative pain continues to be untreated despite the application of multimodal analgesia, medication and new analgesic techniques. Traditional opioid pain treatment has many side effec...

Lidocaine Infusion in Pancreatic Cancer

This study elucidates the effects of the intravenous (IV) lidocaine infusion on the biology of pancreatic circulating tumor cells (CTCs) isolated from patients undergoing robotic pancreate...

Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is ...

Effect of Perioperative Intravenous Lidocaine Infusion in Robotic-Assisted Urologic Surgery

Controlling pain is fundamental during and after surgical procedures. This study examines pain associated with robotic assisted surgery on prostate cancer or a kidney mass. In recent years...

PubMed Articles [19495 Associated PubMed Articles listed on BioPortfolio]

Continuous Intravenous Lidocaine as an Effective Pain Adjunct for Opioid-Induced Bowel Dysfunction: A Case Report.

This case study describes a patient with suspected opioid-induced bowel dysfunction who had improved pain control when treated with intravenous (IV) lidocaine. An 80-year-old man with failed back surg...

Intravenous Lidocaine Does Not Improve Neurologic Outcomes after Cardiac Surgery: A Randomized Controlled Trial.

Preclinical and clinical studies suggest that lidocaine might be neuroprotective, which could benefit surgical patients at risk of neurologic compromise WHAT THIS ARTICLE TELLS US THAT IS NEW: This mu...

Intravenous, Perioperatively Administered Lidocaine Regulates Serum Pain Modulators' Concentrations in Children Undergoing Spinal Surgery.

We analyzed the influence of perioperative, intravenous (i.v.) lidocaine infusion as a part of multimodal anesthesia on concentrations of selected pain modulators.

Comparison of the Anesthetic Efficiency of Lidocaine and Tramadol Hydrochloride in Orthodontic Extractions: A Split-Mouth, Prospective, Randomized, Double-Blind Study.

The aim of the present randomized controlled split-mouth clinical study was to evaluate and compare the clinical anesthetic efficacy of lidocaine and tramadol hydrochloride in orthodontic extractions.

Characterization of Tetracycline Hydrochloride Compounded in a Miracle Mouthwash Formulation.

Miracle mouthwash (MMW) is a commonly prescribed oral formulation compounded with varying active ingredients, depending on purpose of treatment. Due to patient-to-patient customization, the solubility...

Medical and Biotech [MESH] Definitions

Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

Visualization of a vascular system after intravenous injection of a fluorescein solution. The images may be photographed or televised. It is used especially in studying the retinal and uveal vasculature.

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

Intravenous injections of sodium amytal or sodium pentothal to induce a state in which the patient is more relaxed and communicative. Narcosuggestion, narcosynthesis, and narcoanalysis are therapeutic processes using these drug adjuncts.

More From BioPortfolio on "Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain: an Observational Prospective Study"

Quick Search

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Anesthesiology
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...


Searches Linking to this Trial