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临床试验/NCT05176938
NCT05176938Unknown不适用

Effect of Preoperative Ultrasound Guided Thoracic Interfascial Plane Block Versus Preoperative Thoracic Erector Spinae Plane Block on Acute and Chronic Pain After Modified Radical Mastectomy

Tanta University0 个研究点目标入组 90 人开始时间: 2022年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
主要终点
Total analgesics consumption in the first 24h after surgery.

研究概览

简要总结

This study will be conducted to compare the efficacy of ultrasound guided thoracic interfascial plane block versus ultrasound guided erector spinae plane block on acute and chronic pain after modified radical mastectomy surgery.

详细描述

Various thoracic nerve blocks performed for pain control after breast cancer surgery provide superior analgesic effect and reduce postoperative nausea and vomiting as a result of the decreased use of opioid analgesics.

Ultrasound-guided erector spinae block (ESB) is a regional anesthesia technique; recently described by Forero et al, in management of thoracic neuropathic pain. It became popular because it is much safer and easily administered than other alternative regional techniques as paravertebral and thoracic epidural block.

ESB leads to effective postoperative analgesia when performed at T 4-5 level for breast and thoracic surgery, and T 7 level for abdominal surgeries. Spread of local anesthetic following ESB in the cephalic and caudal directions can lead to analgesia from C7 to L2-3.

There have been several reports that thoracic interfascial plane block is useful for multimodal analgesia in patients undergoing mastectomy, Thoracic interfascial plane block including pecto-intercostal fascial plane block (PIFB) and serratus intercostal fascial plane block (SIFB).

Thoracic interfascial plane block is the peripheral nerve block that targets the intercostal nerves branches distributed in the chest and axilla, Although PIFB and SIFB are thought to be relatively easy to perform there have been no reports of the simultaneous performance of the two blocks.

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
Double (Participant, Investigator)

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
否

入选标准

  • •Female patients admitted for modified radical mastectomy surgery.
  • •American Society of Anesthesiologists (ASA) physical activity I, II
  • •Aged (18 - 65) years

排除标准

  • •Patient refusal.
  • •Patient with neurological deficit.
  • •Patient with bleeding disorders (coagulopathy, thrombocytopenia anticoagulant, and antiplatelet drugs).
  • •Uncooperative patient.
  • •Infection at the block injection site.
  • •Patients with a history of allergy to drugs.

研究组 & 干预措施

Ultrasound guided Thoracic Interfascial plane Block (TIFB)

Experimental

Patients will receive (20ml) (plain bupivacaine 0.25% injected in the serratus intercostal space at 6 ribs midaxillary line and (20ml) in pecto-intercostal space at 2 ribs parasternal.

干预措施: Ultrasound guided Thoracic Interfascial plane Block (TIFB) (Procedure)

Ultrasound guided Erector Spinae plane Block (ESPB)

Experimental

Patients will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the fourth thoracic segment (T4).

干预措施: Ultrasound guided Erector Spinae plane Block (ESPB) (Procedure)

General anesthesia

No Intervention

Patients will receive general anesthesia only without blocks.

结局指标

主要结局

Total analgesics consumption in the first 24h after surgery.

时间窗: 24 hours postoperative

Total analgesic consumption (fentanyl intraoperative) and (morphine 0.05 mg / kg per dose at the first 24 h after surgery).

次要结局

  • Complications occurrence (hypotension, pneumothorax, bradycardia)(24 hours Postoperative)
  • Time to first analgesic request after surgery(24 hours Postoperative)
  • Visual Analogue score (VAS)(24 hours Postoperative)

研究者

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

Areeg Kotb Ghalwash

Assistant lecturer of Anesthesiology and Surgical Intensive Care and Pain Medicine

Tanta University

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