Ambulatory Infusions of Lidocaine and Ketamine for Management of Chronic Pain

December 3, 2020 updated by: Allevio Pain Management Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 3S6
        • Allevio Pain Management Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Pain duration > 3 months;

Multifocal and/or non-dermatomal neuropathic pain per Pain Diagram;

Failed medical management with at least 2 neuromodulation agents (e.g., gabapentinoids, antidepressants, cannabinoids);

Neuropathic component (12 or more points on S-LANSS);

Exclusion Criteria:

Non-English speakers;

Refusal to sign informed consent;

Allergy to ketamine and/or lidocaine;

Known relative contraindications to ketamine use which include poorly controlled systemic illnesses: hypertension, hyperthyroidism, ischemic heart disease, heart failure, psychiatric comorbidity (e.g., psychosis, schizophrenia, dissociative state);

Known contraindication to lidocaine use which include current symptomatic or clinically significant brady- or tachyarrhythmia, systolic blood pressure <90 or >180 mmHg;

Scheduled interventions targeting neuropathic pain: epidural injections, peripheral nerve blocks, Bier block, radiofrequency of dorsal root ganglia and peripheral nerves, additional lidocaine or ketamine infusions;

Newly added analgesic or neuromodulating medications within 30 days;

Recently performed neuromodulating interventions within 90 days;

Previous lidocaine-ketamine, lidocaine or ketamine infusion within 6 months;

Acute intoxication or active illegal substance abuse;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lidocaine and ketamine infusion
Drug: Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992

An intravenous will be started. • 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 During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours.

Other Names:
  • ketamine Hydrochloride, Serial# 5751304560, DIN 02246796

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of effectiveness of lidocaine-ketamine infusions: PQAS-R
Time Frame: 4 weeks after the first infusion and every 4 weeks up to 36 weeks
Primary outcome measure: relative change on the PQAS-R. Moderate clinically important improvement is considered as 30% reduction (Dworkin et al., 2008)
4 weeks after the first infusion and every 4 weeks up to 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of lidocaine and ketamine infusion on BDI
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Beck's Depression Inventory
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on PGIC
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Pain Global Improvement and Satisfaction
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on BPI
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Brief Pain Inventory
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on PQAS-R
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Revised Pain Quality Assessment Scale
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on PSEQ
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Patient Self-Efficacy Questionnaire
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on PCS
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on Pain Catastrophizing Scale
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on PSPDE
Time Frame: Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine infusion on viii. Patient self-reported perceived duration of effect
Baseline to end-of-study every 4 weeks up to 36 weeks
Effect of lidocaine and ketamine on narcotic consumption
Time Frame: Baseline to end-of-study up to 36 weeks
Effect of lidocaine and ketamine infusion on narcotic consumption
Baseline to end-of-study up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allevio Pain Management Clinic

Investigators

  • Principal Investigator: Ramin Safakish, MD.FRCPC, Allevio Pain Management Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2017

Primary Completion (Actual)

November 11, 2020

Study Completion (Actual)

November 11, 2020

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16124-11:10:3610-082018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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