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

NCT06974656 | Completed

• 1 other identifier: AP2503-501-100-197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to the 1st rescue analgesia

  Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

  48 hours postoperatively

Secondary Outcomes (5)

• Mean arterial pressure

  Till the end of surgery (Up to 2 hours)

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Total morphine consumption

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

• Incidence of adverse events

  48 hours postoperatively

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Lidocaine group

EXPERIMENTAL

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.

Drug: Lidocaine

Interventions

Dexmedetomidine 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.

Dexmedetomidine group

Lidocaine 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.

Lidocaine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Wmone scheduled for modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: August 20, 2025
• Study Completion: August 20, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)