Acute, Dexmedetomidine, Infusion, Lidocaine, Modified Radical Mastectomy, Postoperative Pain
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGLidocaine
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 48 hours postoperatively | Incidence of adverse events such as hypotension, bradycardia, nausea, vomiting, or any other complications will be recorded. |
| 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. |
| 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. |
Countries
Egypt
Outcome results
None listed