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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • 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

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
Intervention / Treatment
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

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

Cairo University

Investigators

  • 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)

July 25, 2022

Primary Completion (Actual)

August 25, 2025

Study Completion (Actual)

August 25, 2025

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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