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临床试验/NCT06436599
NCT06436599已完成不适用

Comparison of Serratus Posterior Superior Intercostal Plane Block Versus Deep Serratus Anterior Plane Block for Postoperative Analgesia After Breast Surgery: a Prospective Randomized Study

Mustafa Burgac1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年12月13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
发起方
入组人数
62
试验地点
1
主要终点
Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)

研究概览

简要总结

The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

详细描述

Breast surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.

Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.

In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.

Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.

The aim of our study was to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • unilateral mastectomy(modified radial mastectomy)
  • ASA I-III risk group

排除标准

  • Coagulopathy
  • Wound and infection in the block area
  • Local anaesthetic allergy
  • Mental retardation
  • Non-cooperative
  • Pregnant patients

研究组 & 干预措施

Patients with serratus posterior superior intercostal plan block

Active Comparator

Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative analgesia

干预措施: plane block with %0.25 30 ml bupivacaine (Other)

Patients with serratus anterior plan block

Active Comparator

Serratus anterior plane block was applied to a certain group of patients for postoperative analgesia

干预措施: plane block with %0.25 30 ml bupivacaine (Other)

结局指标

主要结局

Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)

时间窗: within 24 hours postoperative

Evaluation of which of the two plan blocks is more effective in postoperative analgesia. Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain.

Comparison of tramadol(mg) consumption

时间窗: within 24 hours postoperative

Using a patient-controlled analgesia device, tramadol consumption and total tramadol consumption will be compared between 0-1st hour, 1st-4th hour, 4th-8th hour, 8th-12th hour, 12th-24th hour postoperatively.

次要结局

  • Comparison of tramadol(mg) consumption(within 24 hours postoperative)
  • patient satisfaction (5-point Likert scale)(24 hours after surgery)
  • perioperative remifentanil consumption(perioperative)
  • Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score(within 24 hours postoperative)
  • rescue anesthesia(within 24 hours postoperative)
  • postoperative nausea-vomiting (PONV)(within 24 hours postoperative)
  • surgeon and patient satisfaction (5-point Likert scale)(24 hours after surgery)

研究者

发起方
Mustafa Burgac
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mustafa Burgac

principal investigator

Istanbul Medeniyet University

研究点 (1)

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