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

Not Applicable

Recruiting

• Conditions: Adjuvants; General Anesthesia; Chronic Pain; Mastectomy; Dexmedetomidine; Lidocaine; Infusion
• Interventions: Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Isotonic saline

• Registration Number: NCT06910644
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Status Verified: 2025-04
• Study First Posted: 2025-04-04
• Study Start: 2025-04-05
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	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	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.
Control group	Isotonic saline	Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

Primary Outcome Measures

Name	Time	Method
Incidence of the chronic pain	6 months postoperatively	Incidence of the chronic pain will be recorded.

Secondary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	48 hours postoperatively	Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Heart rate	Till the end of operation (Up to 2 hours)	Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.
Mean arterial pressure	Till the end of operation (Up to 2 hours)	Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation.
Total morphine consumption	48 hours postoperatively	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.
Degree of pain	12 weeks postoperatively	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.
Incidence of post-mastectomy pain syndrome	6 months postoperatively	Incidence of post-mastectomy pain syndrome will be recorded.
Activity level	12 weeks postoperatively	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 .
Assessment of quality of life	12 weeks postoperatively	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt