Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy

Not Applicable

Recruiting

• Conditions: Infusion; Postoperative Pain; Dexmedetomidine; Lidocaine; Acute; Modified Radical Mastectomy
• Interventions: Drug: Dexmedetomidine; Drug: Lidocaine

• Registration Number: NCT06974656
• Lead Sponsor: Cairo University

Brief Summary

This study aims to compare the effect of intraoperative intravenous infusion of dexmedetomidine and lidocaine in the management of acute postoperative pain after mastectomy.

Detailed Description

Postoperative pain control continues to remain suboptimal, despite multimodal analgesia regimes, minimally invasive surgical techniques, and enhanced recovery programs. Acute postoperative pain hinders patients' functional recovery and represents one of the greatest predictive factors for transition to chronic postsurgical pain.

Among adjuvants, dexmedetomidine, a highly selective α2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, seem promising for this purpose.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study Start: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Age from 18 to 65 years.
• American Society of Anesthesiology (ASA) physical status II.
• Body mass index (BMI) 18.5-35 kg/m2.
• Scheduled for modified radical mastectomy.

Exclusion Criteria

• Patient's refusal.
• Contraindication to the use of local anesthetics.
• Cardiovascular disease.
• Significant renal/hepatic impairment
• Insulin-dependent diabetes mellitus.
• Central nervous system or psychiatric disease.
• Use of opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks.
• Drug/alcohol abuse.
• Inability to comprehend the pain assessment scale.

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 n 0.3-0.5 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 1.5-2 mg/kg/h.

Primary 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.

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	Till the end of surgery (Up to 2 hours)	Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation.
Heart rate	Till the end of surgery (Up to 2 hours)	Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation.
Total morphine consumption	48 hours postoperatively	Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)\> 3 to be repeated after 30 min if pain persists until the VAS \< 4.
Degree of pain	48 hours 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 post-anesthesia care unit (PACU), 2, 4, 8, 12, 24, 36, and 48 h postoperatively.
Incidence of adverse events	48 hours postoperatively	Incidence of adverse events such as hypotension, bradycardia, nausea, vomiting, or any other complications will be recorded.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt