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临床试验/NCT05201963
NCT05201963已完成不适用

Effect of Ultrasound Guided Erector Spinae Plane Block Versus Ultrasound Guided Serratus Anterior Block on the Incidence of Post Mastectomy Pain Syndrome, Randomized Double Blinded Controlled Study

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Incidence of patients developing PMPS.

研究概览

简要总结

Breast cancer is the most common malignancy among females. Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Regionale anesthesia is one of the strategies with the potential to prevent the development of chronic pain following breast surgery. We hypothesize that erector spinae plane block is going to be more effective than serratus anterior plane block in the prevention of postmastectomy pain syndrome.

详细描述

Background and Rationale:

Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. It is the most common cause for cancer-related deaths among women. (1) Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer. It is account for 31% of all breast surgery cases (2). Nearly 40-60% of breast surgery patients experience severe acute postoperative pain, with severe pain persisting for 6-12 months in almost 20-50% of patients (post mastectomy pain syndrome)(3-4). Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities leading to complications such as: shoulder adhesive capsulitis (frozen shoulder), complex regional pain syndrome (causalgia) and altered sensation creating an economic burden for the health care system (5-8).

The International Association for the Study of Pain (IASP) defines PMPS as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm.It usually describes as feeling of burning, stabbing, and pulling around the treatment side(9) The underlying pathophysiology of PMPS is highly complicated and entangle both peripheral and central sensitization. Multiple risk factors involved in the development of PMPS including Acute postoperative pain ,Age < 40 years , Increased BMI ,Diagnosis at later-stage disease , Psychosocial factors (i.e., anxiety, depression, sleep disturbances, catastrophizing) Preoperative pain and Adjuvant therapy (chemotherapy, radiation therapy(10). Like other neuropathic pain conditions, the treatment is a difficult task (11), so the focus of current research is on perioperative measures that can mitigate the modifiable risk factors for PMPS and thereby prevent patients from developing PMPS in the first place. Recognizing the importance of postoperative pain management, a number of studies have looked at strategies with the potential to prevent the development of chronic pain following breast surgery including regional anesthesia. (12)

These regional techniques include: Intercostal nerve block, Pectoral nerve Blocks (PECI & PECS II) , Serratus Anterior Plane block (SAPB) and Erector Spinae Plane Block (ESPB). (14) Hypothesis: We hypothesize that Ultrasound guided erector spinae plane block is going to be more effective than ultrasound guided serratus anterior plane block in the prevention of postmastectomy pain syndrome in patients undergoing MRM as the injected local anesthetics acts on the dorsal and ventral rami of the thoracic spinal nerves and, thus, it is expected to block the sympathetic fibers leading to effective management of somatic and visceral pain.

Objectives:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients
  • Type of surgery; Modified Radical Mastectomy MRM
  • Physical status ASA II, III.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

排除标准

  • Patient refusal.
  • BMI <20 kg/m2 and >35 kg/m2
  • Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
  • History of psychological disorders and/or chronic pain.
  • Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Severe respiratory or cardiac disorders. Advanced liver or kidney disease.
  • Pregnancy.
  • Physical status ASA IV and Male patients.

结局指标

主要结局

Incidence of patients developing PMPS.

时间窗: 6 months

Number and Percentage of patients developing PMPS

次要结局

  • Postoperative Patient's activity level according to Barthel Activities of Daily Living Scale ADL(6 months)
  • Severity of PMPS according to Grading system for neuropathic pain (GSNP)(6 motnths)
  • Total amount of fentanyl consumed intraoperative(Time of surgry)
  • Change in heart rate intraoperative(24 hours)
  • Total amount of morphine consumed postoperatively(24 hours)
  • Patient's Quality of life according to Flanagan Quality of Life Scale (QOLS)(6 motnths)
  • Change in heart rate postoperatively.(24 hours)
  • Complications related to blocks(24 hours)
  • Change in Mean Artertial Blood Pressure (MAP) intraoperative(24 hours)
  • The degree of postoperative sedation according to Ramsay scores.(24 hours)
  • Postoperative nausea and vomiting (PONV).(24 hours)
  • Change in Mean Artertial Blood Pressure (MAP) postoperatively.(24 hours)
  • Time of first rescue analgesia.(24 hours)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Magdy Abdelrahman Elsayed

Assistant Lecturer of Anesthesiology , ICU and Pain Management

National Cancer Institute, Egypt

研究点 (2)

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