Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries

Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Bilevel Erector spinae plane block; Procedure: Bilateral Erector spinae plane block with dexamethasone; Procedure: Bilateral Erector spinae plane block with dexmedetomidine; Drug: Intravenous morphine

Detailed Description

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Walaa Y Elsabeeny

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female patients scheduled for Modified Radical Mastectomy MRM
• Physical status ASA II, III.
• Age (18-65) years
• Body mass index (BMI): (20-35) kg/m2.

Exclusion Criteria:

• Patient refusal.
• Age <18 years or >65 years.
• BMI <20 kg/m2 and >35 kg/m2.
• Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous morphine; Patients will receive intravenous morphine 0.1 mg/kg	Drug: Intravenous morphine; Intravenous morphine 0.1 mg/kg; Other Names: Morphine
Experimental: Bilevel erector spinae plane block; Patients will receive erector spinae plane block at 2 levels	Procedure: Bilevel Erector spinae plane block; Patients will receive bilevel erector spinae plane block with bupivacaine; Other Names: BileveL ESPB
Experimental: Bilevel erector spinae plane block with dexamethasone; Patients will receive erector spinae plane block at 2 levels with dexamethasone	Procedure: Bilateral Erector spinae plane block with dexamethasone; Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone; Other Names: Bilevel ESPB with dexamethasone
Experimental: Bilevel erector spinae plane block with dexmedetomidine; Patients will receive erector spinae plane block at 2 levels with dexmedetomidine	Procedure: Bilateral Erector spinae plane block with dexmedetomidine; Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine; Other Names: Bilevel ESPB with dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption in the first 24 hours postoperatively.	Assessment of total postoperative morphine consumption	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Walaa Y Elsabeeny, MD, Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): September 25, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Enzyme Inhibitors; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexamethasone; Dexamethasone acetate; BB 1101; Morphine; Dexmedetomidine
• Other Study ID Numbers: AP2207-30110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No