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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: Bilateral Erector spinae plane block with dexamethasone; Drug: Intravenous morphine; Procedure: Bilevel Erector spinae plane block; Procedure: Bilateral Erector spinae plane block with dexmedetomidine

• Registration Number: NCT05591417
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-24
• Study Start: 2022-10-27
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilevel erector spinae plane block with dexamethasone	Bilateral Erector spinae plane block with dexamethasone	Patients will receive erector spinae plane block at 2 levels with dexamethasone
Intravenous morphine	Intravenous morphine	Patients will receive intravenous morphine 0.1 mg/kg
Bilevel erector spinae plane block	Bilevel Erector spinae plane block	Patients will receive erector spinae plane block at 2 levels
Bilevel erector spinae plane block with dexmedetomidine	Bilateral Erector spinae plane block with dexmedetomidine	Patients will receive erector spinae plane block at 2 levels with dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Total morphine consumption in the first 24 hours postoperatively.	First 24 hours postoperatively	Assessment of total postoperative morphine consumption

Trial Locations

Locations (1)

Walaa Y Elsabeeny; 🇪🇬 Cairo, Egypt