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临床试验/NCT06750835
NCT06750835尚未招募不适用

Efficacy of the Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Breast Cancer Surgery : A Randomized Comparative Study

Rehab Adel Ebrahim Okely0 个研究点目标入组 90 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
主要终点
Post operative pain relief

研究概览

简要总结

The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a novel regional anesthesia technique targeting the dorsal rami and intercostal nerves (T2-T6), providing sensory blockade to both the posterior and lateral aspects of the chest wall. By blocking these nerves at a more posterior location, the SPSIP block can potentially offer broader and more comprehensive analgesia for breast surgeries, including the axillary and deeper structures of the breast. This makes it a promising alternative or adjunct to the existing regional techniques used in breast cancer surgeries

详细描述

Breast cancer is the most common malignancy among women worldwide, often requiring surgical intervention such as mastectomy or breast-conserving surgery. Despite advancements in surgical techniques, postoperative pain remains a significant concern, as inadequate pain management can lead to delayed recovery, increased opioid consumption, and a higher incidence of chronic pain conditions such as postmastectomy pain syndrome (PMPS). Effective pain control strategies are, therefore, crucial to enhancing patient recovery, reducing hospital stay, and improving overall quality of life [1].

Regional anesthesia techniques have gained prominence as an effective method for perioperative pain management in breast surgery [2]. Traditional blocks such as the Thoracic Paravertebral Block (TPVB) and Serratus Anterior Plane (SAP) Block have been extensively studied and are considered effective options for postoperative analgesia. However, these techniques are not without limitations [3]. The TPVB, although effective, carries a higher risk of complications such as pneumothorax and hypotension due to its proximity to the pleura. The SAP block, on the other hand, primarily provides analgesia to the lateral thoracic wall and may not adequately cover deeper breast tissues and posterior thoracic areas The current study aims to evaluate the efficacy of the SPSIP block for postoperative analgesia in breast cancer surgeries and to compare its analgesic profile with the SAP block and TPVB. By providing a comprehensive comparison, this study seeks to establish the SPSIP block as a viable and potentially superior option for postoperative pain management in breast cancer surgery.

> Patients and methods

• Type of the Study: This is a prospective, randomized controlled cohort study comparing the efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) Block, Serratus Anterior Plane (SAP) Block, and Thoracic Paravertebral Block (PVB) for postoperative analgesia in breast cancer surgery.

• Study Setting: The study will be conducted at Assiut University Hospital, a tertiary care center equipped with advanced facilities for breast cancer surgeries and postoperative pain management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female patients aged 18-75 years.
  • •Scheduled for elective breast cancer surgery (MRM or BCS).
  • •ASA physical status I-II.
  • •Able to provide written informed consent.

排除标准

  • •Chronic pain conditions or long-term opioid use.
  • •Coagulation disorders (platelets < 100,000/mm³ or INR > 1.5).
  • •Severe obesity (BMI > 35 kg/m²).
  • •Allergy to local anesthetics.
  • •Anatomical abnormalities affecting block placement.
  • •Pregnant or lactating women.
  • •Active infection or skin lesions at the injection site.

研究组 & 干预措施

SPSIP block

Active Comparator

Serratus posterior superior intercostal plane block

干预措施: SPSIP block (Procedure)

SAP block

Active Comparator

Serratus anterior plane block

干预措施: SAP block (Procedure)

Paravertebral block

Active Comparator

Paravertebral block

干预措施: Paravertebral block (Procedure)

结局指标

主要结局

Post operative pain relief

时间窗: 24 hours

the level of postoperative pain as assessed by the Numerical Rating Scale (NRS) at rest and during movement at predefined intervals: 1 hour, 6 hours, 12 hours, and 24 hours post-surgery. The NRS is a validated tool that ranges from 0 (no pain) to 10 (worst imaginable pain).

次要结局

  • Total Opioid Consumption(24 hours)
  • Time to First Analgesic Request(24 hours)
  • Incidence of Postoperative Nausea and Vomiting (PONV)(24 hours)

研究者

发起方
Rehab Adel Ebrahim Okely
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rehab Adel Ebrahim Okely

Assistant lecturer

Assiut University

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