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

NCT ID: NCT06910644

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-05

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dexmedetomidine Lidocaine Infusion Adjuvants General Anesthesia Chronic Pain Mastectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type 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.

Control group

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

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type 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.

Intervention Type DRUG

Isotonic saline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elsaid Abdel Fattah

Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed E Abdel Fattah, MD

Role: CONTACT

00201284475792

Facility Contacts

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Mohamed E Abdel Fattah, MD

Role: primary

00201284475792

Other Identifiers

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AP2411-501-087-193

Identifier Type: -

Identifier Source: org_study_id

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