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Clinical trial

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

ID
Name
AP2207-30110
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.
Trial arms
Trial start
2022-10-27
Estimated PCD
2024-10-27
Trial end
2024-11-10
Status
Recruiting
Treatment
Bilevel Erector spinae plane block
Patients will receive bilevel erector spinae plane block with bupivacaine
Arms:
Bilevel erector spinae plane block
Other names:
BileveL ESPB
Bilateral Erector spinae plane block with dexamethasone
Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone
Arms:
Bilevel erector spinae plane block with dexamethasone
Other names:
Bilevel ESPB with dexamethasone
Bilateral Erector spinae plane block with dexmedetomidine
Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine
Arms:
Bilevel erector spinae plane block with dexmedetomidine
Other names:
Bilevel ESPB with dexmedetomidine
Intravenous morphine
Intravenous morphine 0.1 mg/kg
Arms:
Intravenous morphine
Other names:
Morphine
Size
60
Primary endpoint
Total morphine consumption in the first 24 hours postoperatively.
First 24 hours postoperatively
Eligibility 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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-01-18

1 organization

1 product

1 indication

Organization
National Cancer Institute, Egypt
Product
Morphine
Indication
Analgesic