Lidocaine IV Injection With Different Doses for Patients With Neuropathic Pain After Mastectomy

March 11, 2026 updated by: Ahmed Shaaban Glall Ismail, Cairo University

Comparative Study of Lidocaine IV Injection With Two Different Doses for Patients With Neuropathic Pain Who Undergoing Mastectomy for Cancer Breast

cancer has become the most common malignancy affecting women worldwide, and its incidence is increasing annually. According to the Global Cancer Observatory (GLOBOCAN) 2020 published by the International Agency for Research on Cancer of the World Health Organization, female breast cancer is the cancer with the highest number of new cases worldwide significant number of patients experiencing moderate to severe acute pain (30-50%) and developing chronic post-surgical pain (CPSP) (25-68%)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Various drugs have been used for neuropathic pain management Opioid agonists, but endocrine and immunologic alterations were reported. Concerns about an increase in opioid prescription that is associated with overdose mortality, misuse and other opioid related morbidity resulted in tracking daily doses and monitoring patients, who require higher daily doses, more closely, Tramadol has been found moderately effective in peripheral neuropathic pain, yet it should be used with caution in elderly patients for risk of confusion. Other medications developed for other indications like anti-depressants and anti-convulsants. Tricyclic antidepressants (TCA's), selective serotonin nor epinephrine reuptake inhibitors (SNRI's), monoamine oxidase inhibitors (MAO inhibitors) are antidepressant agents that reduce chronic neuropathic pain in addition to their role in treatment of depression and pain related sleep interference, However, their induced sedation and dizziness interfered with patients' quality of life and their doses as well should be monitored for patients with renal insufficiency However, TCA's may cause cardiac conduction block, orthostatic hypotension, sedation, and confusion. SNRI's and MAO inhibitors cause nausea, loss of appetite, constipation, sedation, and anxiety Lidocaine is an amide local anesthetic with a wide range of mechanisms of action. Lidocaine found to successfully provide pain relief in several chronic neuropathic conditions that have failed other treatment modalities when given in low dose intravenous infusion. Lidocaine infusion is inexpensive, relatively easily administrated and has been safely used with few side effects. It also has opioid sparing effect.

It has been reported that even single infusion may lead to prolonged analgesia that could allow the reduction of use of co-analgesics and related toxicities, Hence, in the current study, the investigators aim to compare of lidocaine iv injection with two different doses for patients with neuropathic pain developed after mastectomy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Egypt
      • Cairo, Egypt
        • National Cancer Institute, Cairo University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥ 18years.
  • Females with neuropathic pain following mastectomy for cancer breast.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Patients on other drugs with intolerable side effects.
  • Patients undergoing breast surgery

Exclusion Criteria:

  • Patients with known hypersensitivity to lidocaine.
  • Patients with history of uncontrolled seizures.
  • Patients with second- or third-degree heart block.
  • Patients with altered cognitive dysfunction.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lidocaine 2 mg/kg
Patients receive 2 mg/kg lidocaine IV injection over 30 minutes.
Drug: Lidocaine 2%
Lidocaine 2 mg/kg IV injection over 30 minutes
Active Comparator: Lidocaine 6 mg/kg
Patients receive 6 mg/kg lidocaine IV injection over 30 minutes
Drug: Lidocaine
Lidocaine 6 mg/kg IV injection over 30 minutes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To assess neuropathic pain scale
Time Frame: assessed at 0, 15, 30, 1 hour. 2 hours and 24 hours and 1 week after injection
a 10-item tool designed to assess the distinct qualities (e.g., burning, freezing, stinging) and intensity of nerve-related pain, using 0-10 numerical ratings for each.This scale measures 10 specific qualities associated with neuropathic pain; 7 of the 10 pain qualities contain the words: intense, sharp, hot, dull, cold, and itchy to characterize the patient's pain, and the word "sensitive" describes the patient's pain reaction to light touch or clothing. One item describes the pain in regard to time (all the time or some of the time). The ninth item describes the overall unpleasantness of the pain, and the last item indicates the intensity of the deep and surface pain. It helps distinguish neuropathic from other pain types.
assessed at 0, 15, 30, 1 hour. 2 hours and 24 hours and 1 week after injection

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mai Helaly, Professor, National Cancer Institute, Cairo University
  • Study Chair: Ehab Hanafy Gendy, Professor, National Cancer Institute, Cairo University
  • Study Chair: Maie El Rawas, National Cancer Institute, Cairo University
  • Study Chair: Fady Samy Saad, National Cancer Institute, Cairo University
  • Principal Investigator: Vivian Shoukry Hannah, National Cancer Institute, Cairo University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2107-301-031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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