Completed

Lidocaine IV Infusion in Two Doses for Neuropathic Pain Post-Mastectomy

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Study Aim

This study aims to prevent neuropathic pain post-mastectomy by administering Lidocaine IV in two doses, with the primary outcome being the assessment of your pain using a 10-item neuropathic pain scale.

What is being tested

Lidocaine 2%

+ Lidocaine

Drug
Who is being recruted

Nervous System Diseases+5

+ Neuralgia

+ Neurologic Manifestations

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: July 2022
See protocol details

Summary

Principal SponsorCairo University
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 25, 2022

Actual date on which the first participant was enrolled.

This study focuses on managing neuropathic pain, a type of pain often experienced by patients who have undergone mastectomy for breast cancer. The pain can be challenging to manage, with various drugs like opioids and antidepressants used, but these come with side effects. The study aims to find a safer and more effective solution by comparing two different doses of Lidocaine, an amide local anesthetic. Lidocaine has been found to provide pain relief in several chronic neuropathic conditions with fewer side effects. It's also known to have an opioid-sparing effect, meaning it can reduce the need for opioids. The study hopes to improve care for patients experiencing neuropathic pain after mastectomy. During the study, participants will receive Lidocaine through an IV injection. The study's primary goal is to assess the neuropathic pain scale, a tool designed to measure the distinct qualities and intensity of nerve-related pain. This scale helps distinguish neuropathic pain from other types of pain. It evaluates 10 specific qualities associated with neuropathic pain, such as burning, freezing, and stinging, using a 0-10 numerical rating for each. The study aims to understand how effectively Lidocaine manages these symptoms and improves the overall quality of life for patients.

Official TitleComparative Study of Lidocaine IV Injection With Two Different Doses for Patients With Neuropathic Pain Who Undergoing Mastectomy for Cancer Breast
Principal SponsorCairo University
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

5 inclusion criteria required to participate
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

Show More Criteria

4 exclusion criteria prevent from participating
Patients with second- or third-degree heart block

Patients with known hypersensitivity to lidocaine

Patients with history of uncontrolled seizures

Patients with altered cognitive dysfunction

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients receive 2 mg/kg lidocaine IV injection over 30 minutes.

Group II

Active Comparator
Patients receive 6 mg/kg lidocaine IV injection over 30 minutes

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Cancer Institute, Cairo University

Cairo, EgyptOpen National Cancer Institute, Cairo University in Google Maps
CompletedOne Study Center