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

Sponsor
National Cancer Institute, Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05591417
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
12.5
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy
Actual Study Start Date :
Oct 27, 2022
Anticipated Primary Completion Date :
Oct 27, 2023
Anticipated Study Completion Date :
Nov 10, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total morphine consumption in the first 24 hours postoperatively. [First 24 hours postoperatively]

      Assessment of total postoperative morphine consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walaa Y Elsabeeny Cairo Egypt 11796

    Sponsors and Collaborators

    • National Cancer Institute, Egypt

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Walaa Youssef Elsabeeny, Assistant professor of Anesthesia and Pain management, National Cancer Institute, Egypt
    ClinicalTrials.gov Identifier:
    NCT05591417
    Other Study ID Numbers:
    • AP2207-30110
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Jan 10, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexamethasone
    Dexamethasone acetate
    Dexmedetomidine
    Morphine
    BB 1101

    Study Results

    No Results Posted as of Jan 10, 2023