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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591417
• Other study ID #: AP2207-30110
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: November 10, 2024

Study information

• Verified date: January 2024
• Source: National Cancer Institute, Egypt
• Contact: Walaa Y Elsabeeny, MD
• Phone: +201007798466
• Email: walaa.elsabeeny[@]nci.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 10, 2024
• Est. primary completion date: October 27, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Bilevel Erector spinae plane block
Patients will receive bilevel erector spinae plane block with bupivacaine
• Bilateral Erector spinae plane block with dexamethasone
Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone
• Bilateral Erector spinae plane block with dexmedetomidine
Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine

Drug:
• Intravenous morphine
Intravenous morphine 0.1 mg/kg

Locations

Country	Name	City	State
Egypt	Walaa Y Elsabeeny	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption in the first 24 hours postoperatively.	Assessment of total postoperative morphine consumption	First 24 hours postoperatively