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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

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