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

NCT ID: NCT06974656

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-08-20

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.

Conditions

Infusion; Dexmedetomidine; Lidocaine; Acute; Postoperative Pain; Modified Radical Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine group

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.

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

Interventions

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.

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 1.5-2 mg/kg/h.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

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

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP2503-501-100-197

Identifier Type: -

Identifier Source: org_study_id