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

Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; General Anesthesia; Dexmedetomidine; Mastectomy; Lidocaine; Infusion; Adjuvants
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Isotonic saline

Detailed Description

Chronic pain after breast cancer surgery is a significant problem that is expected to become more relevant because the number of patients undergoing breast cancer surgery is increasing owing to the longer survival associated with this surgery.

Lidocaine is the local anesthetic, which is used more often, and it is considered the prototype of amino-amide local anesthetics. Dexmedetomidine (DEX) is a highly selective agonist that acts by binding with presynaptic alpha 2-adrenergic receptor and then activating the negative feedback loop of the sympathetic nerve response, leading to inhibited norepinephrine release from the sympathetic terminals and decreased reflex activity of the sympathetic nervous.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed E Abdel Fattah, MD; Phone Number: 00201284475792; Email: mohamed-elsaid@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Contact: Mohamed E Abdel Fattah, MD; Phone Number: 00201284475792; Email: mohamed-elsaid@cu.edu.eg
    • Principal Investigator: Samuel F Samy, MD
    • Principal Investigator: Norma O Zayed, MD
    • Principal Investigator: Mohammed ElSharkawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; 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; Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
Experimental: Lidocaine group; 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; 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.
Placebo Comparator: Control group; Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.	Drug: Isotonic saline; Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the chronic pain	Incidence of the chronic pain will be recorded.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the 1st rescue analgesia	Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.	48 hours postoperatively
Heart rate	Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.	Till the end of operation (Up to 2 hours)
Mean arterial pressure	Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.	Till the end of operation (Up to 2 hours)
Total morphine consumption	Rescue analgesia of morphine 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses will be given if the visual analogue scale (VAS)>3.	48 hours postoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at PACU, 1, 2, 4, 6, 8, 12, 18, 24, 36, 48 h,1, 2, 3, 4, 8, and 12 weeks postoperatively.	12 weeks postoperatively
Incidence of post-mastectomy pain syndrome	Incidence of post-mastectomy pain syndrome will be recorded.	6 months postoperatively
Activity level	The activity level will be assessed using the Barthel Activities of Daily Living scale (ADL) 2, 3, 4, 8 and 12 weeks postoperatively. This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help .	12 weeks postoperatively
Assessment of quality of life	Quality of life will be assessed using the Flanagan Quality of Life Scale (QOLS), which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patients by the pain physician, and the total score will be calculated and recorded at the preoperative assessment (baseline) and at 2, 3, 4, 8 and 12 weeks postoperatively.	12 weeks postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Lidocaine; Dexmedetomidine
• Other Study ID Numbers: AP2411-501-087-193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No