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Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block

A

Al-Azhar University

Status and phase

Not yet enrolling
Phase 4

Conditions

Breast Cancer

Treatments

Drug: Dexamethasone
Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT06300099
AZAST/Research/52/20-Jan-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 estimated patients

Sex

Female

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

126 participants in 2 patient groups

Dexamethasone
Active Comparator group
Description:
Dexamethasone injection
Treatment:
Drug: Dexamethasone
Dexmedetomidine
Active Comparator group
Description:
Dexmedetomidine injection.
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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