Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy

NCT06910644 | Recruiting

• 1 other identifier: AP2411-501-087-193
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.

Conditions

Dexmedetomidine; Lidocaine; Infusion; Adjuvants; General Anesthesia; Chronic Pain; Mastectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of the chronic pain

  Incidence of the chronic pain will be recorded.

  6 months postoperatively

Secondary Outcomes (8)

• Time to the 1st rescue analgesia

  48 hours postoperatively

• Heart rate

  Till the end of operation (Up to 2 hours)

• Mean arterial pressure

  Till the end of operation (Up to 2 hours)

• Total morphine consumption

  48 hours postoperatively

• Degree of pain

  12 weeks postoperatively

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL

Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.

Drug: Dexmedetomidine

Lidocaine group

EXPERIMENTAL

Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h.

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

Drug: Isotonic saline

Interventions

Dexmedetomidine DRUG

Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.

Dexmedetomidine group

Lidocaine DRUG

Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h.

Lidocaine group

Isotonic saline DRUG

Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Women scheduled for mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years.
• American Society of Anesthesiologists (ASA) physical status II.
• Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.

You may not qualify if:

• Patient refusal.
• Known allergy to any of the study drugs.
• Those with hepatic or renal insufficiency.
• Patients who are running regularly on B blockers.
• α2 adrenergic agonists and sedatives.
• Psychoactive medications.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Dexmedetomidine; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Mohamed E Abdel Fattah, MD

CONTACT

00201284475792; mohamed-elsaid@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: April 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)