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临床试验/NCT07747623
NCT07747623招募中不适用

Comparison of the Efficiency of One-Level and Bi-Level ESPB ESPB for Postoperative Analgesia in Patients Undergoing Breast Surgery

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
2
主要终点
Pain scores

研究概览

简要总结

Acute pain after breast surgery can significantly reduce the quality of life for patients. If acute pain is not adequately treated, it can develop into chronic pain. Thoracic epidural analgesia, thoracic paravertebral block, erector spinae plane block, and serratus anterior plane block are frequently applied blocks. However, ESPB, being a fascial plane block, can yield inconsistent results regarding distribution and dermatomal area. In recent years, there has been an increase in publications applying ESPB from two levels to achieve wider distribution. As a result, this study aims to compare the analgesic efficacy of single-level (Thoracic 3) and two-level (Thoracic 2, Thoracic 4) ESPB applications.

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
Single (Outcomes Assessor)

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

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18 and 30 kg/m²
  • Patients undergoing elective breast surgery

排除标准

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area

研究组 & 干预措施

One-level Erector Spinae Plane Block

Active Comparator

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T3 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.

干预措施: One-level Erector Spinae Plane Block (Procedure)

Bi-level Erector Spinae Plane Block

Active Comparator

After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T2 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T4 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

干预措施: Bi-level Erector Spinae Plane Block (Procedure)

结局指标

主要结局

Pain scores

时间窗: 4th-hour after surgery

Pain will be assessed at the 4th-hour rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain).

次要结局

  • Pain scores(Up to 24 hours after surgery)
  • Tramadol Consumption(Up to 24 hours after surgery)
  • Side effects(Up to 24 hours after surgery)

研究者

发起方
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Zengin

Principal İnvestigator

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

研究点 (2)

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