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临床试验/NCT05427955
NCT05427955已完成不适用

Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月20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
60
试验地点
2
主要终点
Pain scores

研究概览

简要总结

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.

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, Outcomes Assessor)

入排标准

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

入选标准

  • •Age between 18 and 80 years
  • •American Society of Anesthesiologists physical status I-II-III
  • •Body mass index between 18-40 kg/m2
  • •Patients undergoing elective video-assisted thoracoscopic 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
  • •Emergency surgery

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 T5 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 T4 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 T6 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: 48th-hour after surgery.

Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain scores

时间窗: 2nd-hour after surgery.

Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain scores

时间窗: 1st hour after surgery

Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain scores

时间窗: 4th-hour after surgery.

Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain scores

时间窗: 12th-hour after surgery.

Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Pain scores

时间窗: 24th-hour after surgery.

Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

次要结局

  • Morphine Consumption(24 hours after surgery)

研究者

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

Nilgün Zengin

Principal İnvestigator

Ankara City Hospital Bilkent

研究点 (2)

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