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

Cairo University40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Infusion Dexmedetomidine Lidocaine Acute Postoperative Pain Modified Radical Mastectomy

Interventions

DexmedetomidineDRUG

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.

LidocaineDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 48 hours postoperatively

Secondary Outcomes

Mean arterial pressure

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.

Time frame: Till the end of surgery (Up to 2 hours)

Heart rate

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.

Time frame: Till the end of surgery (Up to 2 hours)

Total morphine consumption

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.

Time frame: 48 hours postoperatively

Degree of pain

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.

Time frame: 48 hours postoperatively

Incidence of adverse events

Incidence of adverse events such as hypotension, bradycardia, nausea, vomiting, or any other complications will be recorded.

Time frame: 48 hours postoperatively

Data from ClinicalTrials.gov

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