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临床试验/NCT06300099
NCT06300099尚未招募4 期

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

Al-Azhar University0 个研究点目标入组 126 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
126
主要终点
postoperative visual assessment scale for pain.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy

排除标准

  • 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.

研究组 & 干预措施

Dexamethasone

Active Comparator

Dexamethasone injection

干预措施: Dexamethasone (Drug)

Dexmedetomidine

Active Comparator

Dexmedetomidine injection.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

postoperative visual assessment scale for pain.

时间窗: 72 hours postoperative

Subjective pain assessment scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Warda Demerdash Khalifa Ali

Principal investigator

Al-Azhar University

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