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

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ClinicalTrials.gov Identifier: NCT05591417
Recruitment Status : Recruiting
First Posted : October 24, 2022
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Study Description
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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
Analgesia 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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 27, 2022
Estimated Primary Completion Date : October 27, 2023
Estimated Study Completion Date : November 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Bilevel ESPB with dexmedetomidine


Outcome Measures
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Primary Outcome Measures :
  1. Total morphine consumption in the first 24 hours postoperatively. [ Time Frame: First 24 hours postoperatively ]
    Assessment of total postoperative morphine consumption


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05591417


Contacts
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Contact: Walaa Y Elsabeeny, MD +201007798466 ext +2 walaa.elsabeeny@nci.cu.edu.eg
Contact: Reham M Fahmy, M.Sc 01066551643 ext +2 Rehammahmoudamr@gmail.com

Locations
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Egypt
Walaa Y Elsabeeny Recruiting
Cairo, Egypt, 11796
Contact: Walaa Y Elsabeeny, MD    +201007798466 ext +2    walaa.elsabeeny@nci.cu.edu.eg   
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Principal Investigator: Walaa Y Elsabeeny, MD Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
More Information
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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: October 24, 2022    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Morphine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Analgesics, Opioid