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临床试验/NCT05080985
NCT05080985已完成不适用

Paravertebral Block Versus Erector Spinae Plane Block for Analgesia and Opioid Consumption in Modified Radical Mastectomy; Randomized, Prospective, Double Blind

Istanbul University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年11月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

The study is planned to be a single-center randomized, prospective double-blind study and includes patients who planned to be done unilateral MRM (modified radical mastectomy) operation in Istanbul University Istanbul Faculty of Medicine. The objective of this study is to compare postoperative analgesic efficacies of TPVB (thoracic paravertebral block) and ESPB (erector spinae plane block) performed under ultrasound (USG) guidance after MRM. Primary outcome of this study is postoperative 24-hour morphine consumption whereas secondary outcomes were planned as the comparison of changes in hemodynamic parameters and numeric rating pain score (NRS).

详细描述

A total of 86 patients were randomized into TPVB (Group P) and ESPB (Group E) by using closed envelopes.

All patients in the operating room has same anesthetic management under standard monitoring modalities. Prior to regional technique, mild sedation was achieved with midazolam (1-2 mg) and fentanyl (50 mcg). Both blocks were performed under ultrasonography guidance from the level of T4 vertebra with a linear probe (5MHz; GE Healthcare, Wauwatosa, Wis, USA) using longitudinally out-of-plane technique by an anesthesiologist. A 22-gauge, 50 mm insulated stimulating needle was used.By using reference points of C7 and T7, spinous processes of thoracic vertebras were marked. 10% povidone iodine was used for skin antisepsis. USG probe was longitudinally placed at the level of T4. Staff anesthesiologist had to visualize of adjacent muscles, transverse process (TP) and pleura.

For ESPB; confirmation of the needle position was achieved with spread of 2 ml saline between the deep fascia of the erector spinae muscle and the TP. After negative aspiration 20 ml 0.375% bupivacaine was injected with appropriate distribution of LA.

For TPVB; the needle was advanced passing over superior costotransverse ligament and target space was confirmed by the downward displacement of pleura after the administration of 2 ml 0.9% NaCl. After negative aspiration, 20 ml 0.375 % bupivacaine was injected with appropriate distribution of local anesthetics.

Vascular puncture, haematoma, neuraxial injury and pneumothorax were defined as block complications and should be noted.

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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • unilateral MRM
  • ages 18-75 years
  • American Society of Anesthesiologists (ASA) classification I-III

排除标准

  • presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
  • chronic analgesic use
  • diabetes mellitus
  • body mass index of (BMI) > 35 kg/m2.

研究组 & 干预措施

Group P : TPVB

Experimental

Thoracic paravertebral block

干预措施: TPVB (Procedure)

Group P : TPVB

Experimental

Thoracic paravertebral block

干预措施: Bupivacain (Drug)

Group E : ESPB

Experimental

Erector spinae plane block

干预措施: ESPB (Procedure)

Group E : ESPB

Experimental

Erector spinae plane block

干预措施: Bupivacain (Drug)

结局指标

主要结局

Morphine consumption

时间窗: postoperative 24 hours

amount of postoperative 24 hours morphine consumption

次要结局

  • number of blocked dermatome(30 minutes after block)
  • intraoperative heart rate(during surgery)
  • Static and dynamic pain score assessed with Numeric Rating Scale (NRS).(postoperative 24 hours)
  • intraoperative mean arterial pressure(during surgery)
  • nause and vomit(postoperative 24 hours)

研究者

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

Nukhet Sivrikoz

Attending Anesthesiologist

Istanbul University

研究点 (1)

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