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临床试验/NCT06225908
NCT06225908已完成不适用

The Effects of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery

Zonguldak Bulent Ecevit University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月18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
60
试验地点
2
主要终点
opioid consumption

研究概览

简要总结

Acute postoperative pain after breast cancer surgery is usually moderate to severe, and inadequate postoperative pain management can significantly increase perioperative analgesic consumption, prolong hospital stay, and even cause long-term persistent pain such as postmastectomy pain syndrome. A multimodal analgesic approach (NSAII, paracetamol, opioids, local infiltration, facial plane blocks and paravertebral and periparavertebral blocks) is recommended.

Paravertebral block (PVB) is considered the gold standard analgesic method for breast surgery. However, PVB is an invasive block requiring advanced skills and deep injection in close proximity to the pleura, intercostal nerves, neuraxis, great vessels and intercostal neurovascular bundles. As a result, the ongoing risks of pneumothorax, neuraxial spread, hypotension and systemic toxicity preclude its routine use in the day surgery setting. Therefore, alternative blocks have been developed. Various regional techniques such as Serratus plan block (SPB), interpectoral/pectoroserratus blocks (PECS I/II), erector spina plan block (ESPB) and rhomboid intercostal plan block (RIB) have been used to relieve pain after breast surgery. However, local anesthetic distribution may be affected by the surgical incision in the chest muscles. ESPB can be performed from cervical to sacral vertebrae, but clinical, cadaveric and radiologic results are inconsistent. RIB provides hemithoracic analgesia; however, RIB does not cover the cranial aspect of the T2 dermatome. A meta-analysis reported that SPB effectively relieves acute postoperative pain, reduces nausea and vomiting, and improves perioperative anesthesia outcomes in breast surgery. In another study compared with placebo, it was reported that serratus plane block provided less pain at rest, but there was no significant difference in reducing postoperative opioid consumption.

Serratus Posterior Superior Intercostal Plan Block is performed in the fascial plane between the serratus posterior superior muscle and intercostal muscles at the second and third costal level. SPSIB provides hemithoracic analgesia from the paraspinal region to the anteromedial region of the chest wall including the axillary region. In a case series of patients undergoing breast surgery, it was reported that the costal plane plays an important role in preventing pneumothorax, provides a natural barrier to the pleura, and may be a good choice for postoperative analgesia management as part of multimodal analgesia after breast surgery.

In this study, the investigators aimed to observationally investigate the effect of serratus posterior superior intercostal plane block on postoperative opioid consumption in patients undergoing breast cancer surgery under general anesthesia.

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 (Care Provider, 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

  • 18-65 years old
  • ASA I-II-III risk group
  • Patients whose consent was obtained with an informed consent form
  • Breast Cancer Surgery operation patients who will undergo

排除标准

  • Under 18 and over 65
  • History of allergy to local anesthetics
  • Known coagulation disorders
  • Infection near the entry site
  • Chronic use of analgesics
  • Diabetes Mellitus and patients receiving neoadjuvant chemotherapy
  • Body Mass index over 30
  • Dementia or confusion
  • Lack of cooperation

结局指标

主要结局

opioid consumption

时间窗: up to 24 hour after surgery

total consumption of opioid during 24 hour after surgery

次要结局

  • Pain scores(up to 24 hour after surgery)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bengü Gülhan Köksal

Principal Investigator

Zonguldak Bulent Ecevit University

研究点 (2)

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