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Completed

NCT Number: NCT07475520

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

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%)

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine 2%

Drug

Lidocaine 2 mg/kg IV injection over 30 minutes

Lidocaine

Drug

Lidocaine 6 mg/kg IV injection over 30 minutes

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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