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

Cairo University (CU)

Status: Enrolling

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

Treatments: Drug: Lidocaine; Drug: Dexmedetomidine; Drug: Isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06910644

AP2411-501-087-193

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Lidocaine group

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Isotonic saline