NCT07475520

Brief Summary

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%)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
Last Updated

March 16, 2026

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

March 8, 2026

Last Update Submit

March 11, 2026

Conditions

Neuropathic Pain Induced by Mastectomy

Keywords

Neuropathic painmastectomyLidocaine

Outcome Measures

Primary Outcomes (1)

  • To assess neuropathic pain scale

    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

Study Arms (2)

Lidocaine 2 mg/kg

ACTIVE COMPARATOR

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

Drug: Lidocaine 2%

Lidocaine 6 mg/kg

ACTIVE COMPARATOR

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

Drug: Lidocaine

Interventions

Lidocaine 2%DRUG

Lidocaine 2 mg/kg IV injection over 30 minutes

Lidocaine 2 mg/kg
LidocaineDRUG

Lidocaine 6 mg/kg IV injection over 30 minutes

Lidocaine 6 mg/kg

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mai Helaly, Professor

    National cancer institute, cairo university

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

  • Vivian Shoukry Hannah

    National cancer institute, cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 16, 2026

Study Start

July 25, 2022

Primary Completion

August 25, 2025

Study Completion

August 25, 2025

Last Updated

March 16, 2026

Record last verified: 2022-07

Locations

EG(1)