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Trial Title:
Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block
NCT ID:
NCT06300099
Condition:
Breast Cancer
Conditions: Official terms:
Dexamethasone
Dexmedetomidine
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone as adjunct to serratus anterior plane block.
Arm group label:
Dexamethasone
Intervention type:
Drug
Intervention name:
Dexmedetomidine
Description:
Dexmedetomidine as adjunct to serratus anterior plane block.
Arm group label:
Dexmedetomidine
Summary:
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.
Detailed 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.
Serratus anterior plane block (SAPB) with ultrasound guidance is a fascial plane block
that proved to be feasible, safe and effective tool for reduction of postoperative pain
after thoracic and breast surgeries. In multiple instances, SAPB is used with additional
adjuncts e.g. dexamethasone or dexmedetomidine to improve analgesic potency and duration.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
20 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
October 1, 2024
Lead sponsor:
Agency:
Al-Azhar University
Agency class:
Other
Source:
Al-Azhar University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06300099