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临床试验/NCT06714682
NCT06714682已完成不适用

Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Erector Spinae Plane Block (ESPB) for Postoperative Analgesia of Modified Radical Mastectomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6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
已完成
入组人数
20
试验地点
1
主要终点
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.

研究概览

简要总结

The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.

详细描述

During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs .

Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality .

PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block .

ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .

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
None (Participant, Care Provider)

入排标准

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

入选标准

  • •Female patients scheduled for MRM.
  • •Age eligible ≥ 40 & ≤ 65 yrs.
  • •Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.

排除标准

  • •Age < 40 & > 65 years old.
  • •Declining to give written informed consent.
  • •History of allergy to the medications used in the study.
  • •Contraindication to regional anesthesia [including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection].
  • •Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
  • •Renal dysfunction [GFR < 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)].
  • •Psychiatric disorder.
  • •Patient with history of thoracic spine surgery.

研究组 & 干预措施

Ultrasound-Guided Modified Pectoral Plane Block group

Active Comparator

first group 10 patients

干预措施: Modified Pectoral Plane block group (Procedure)

Erector Spinae Plane Block group

Active Comparator

second group 10 patients

干预措施: Erector spinae plane block group. (Procedure)

结局指标

主要结局

Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.

时间窗: will be evaluated postoperatively on arrival to PACU (zero time)

Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome

次要结局

  • Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.(24 hours post-operative)

研究者

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

mohamed ibrahim hassan mohamed

lecturer of anesthesia, intensive care and pain management

Ain Shams University

研究点 (1)

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