Clinical trial

Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block for Postoperative Analgesia After Modified Radical Mastectomy A Randomized Clinical Study

Name
AZAST/Research/52/20-Jan-2024
Description
Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results. The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Dexamethasone
Dexamethasone as adjunct to serratus anterior plane block.
Arms:
Dexamethasone
Dexmedetomidine
Dexmedetomidine as adjunct to serratus anterior plane block.
Arms:
Dexmedetomidine
Size
126
Primary endpoint
postoperative visual assessment scale for pain.
72 hours postoperative
Eligibility criteria
Inclusion Criteria: Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy Exclusion Criteria: Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2024-03-12

1 organization

1 product

1 drug

1 indication

Indication
Breast Cancer