Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexamethasone

Dexamethasone injection

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone as adjunct to serratus anterior plane block.

Dexmedetomidine

Dexmedetomidine injection.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine as adjunct to serratus anterior plane block.

Interventions

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Dexamethasone

Dexamethasone as adjunct to serratus anterior plane block.

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine as adjunct to serratus anterior plane block.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No