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临床试验/NCT04457986
NCT04457986已完成4 期

Randomized Controlled Comparison of the Erector Spina Plane Block and Modified Thoracolumbar Interfacial Plane Block and Intravenous Patient Controlled Analgesia in Patients Undergoing Lumbar Disc Surgery

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
81
试验地点
1
主要终点
Time to first analgesia request

研究概览

简要总结

Acute postoperative pain begins with surgical trauma and decreases with tissue healing. Untreatable postoperative pain is one of the most important problems due to the increase in respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely performed, and patients often complain of postoperative pain.

Preventing and managing postoperative pain after lumber disc surgery is very important for anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids, preemptive analgesia methods, intravenous patient controlled analgesia methods and regional anesthesia techniques are used within the multimodal analgesia strategy.

Regional anesthesia techniques are becoming increasingly widespread due to their efficiency and increased applicability thanks to the use of ultrasonography. Regional anesthesia techniques used in lumber disc surgery include paravertebral block, local anesthetic infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar interfacial plan block in recent years.

The erector spina plane block was first described in 2016, and the thoracolumbar interfacial plane block in 2015, and its modification was developed in 2017. Although they vary depending on the level of application, they offer analgesic activity in a wide range. Although there are publications about the use of these blocks for postoperative analgesia after lumber surgeries, which block is more effective has not been investigated.

This study may contribute to the development of new options for pain management after lumber disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial plane block, which have recently been used for postoperative pain treatment, with limited research, with each other and the standard technique, intravenous patient controlled analgesia, can add new applications to multimodal analgesia methods, increase patient satisfaction and contribute to the early recovery process.

The objective is to compare the erector spina plane block and modified thoracolumbar interfacial plane block in patients undergoing lumber disc surgery with intravenous patient-controlled analgesia in terms of analgesic efficacy.

Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block may decrease the postoperative pain scores, opioid consumption and time to first analgesic requirement compared with intravenous patient controlled analgesia.

详细描述

Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or Intravenous patient controlled analgesia IV-PCA.

Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the preoperative holding area.

All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated with a numeric rating scale at postoperative recovery room admittance, postoperative 1st , second, 4th, 12th and 24th hours both at rest and during movement.

Postoperative tramadol consumption and time to first tramadol demand will be determined.

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)

盲法说明

Postoperative pain will be assessed by an anaesthesiologist unaware of group assignment

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective lumber discectomy or laminectomy
  • Aged 18-65
  • America Society of Anesthesiologists physical status I-III

排除标准

  • Emergency surgery
  • Chronic pain condition
  • Allergic to study drugs
  • Recurrent surgical cases

研究组 & 干预措施

Erector spina plane block (ESP)

Experimental

Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia

干预措施: Erector spina plane block (ESP) (Drug)

Modified thoracolumbar interfacial plane block (MTI)

Experimental

Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia

干预措施: Modified thoracolumbar interfacial plane block (MTI) (Drug)

Intravenous patient controlled analgesia (IV-PCA)

Active Comparator

Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia

干预措施: Intravenous patient controlled analgesia (IV-PCA) (Drug)

结局指标

主要结局

Time to first analgesia request

时间窗: 10 minutes after extubation

Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)

Pain score

时间窗: postoperative 24th hour

Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)

Tramadol consumption

时间窗: postoperative 24th hour

Tramadol consumption will be determined from the ambulatory infusion pump (Abott)

次要结局

未报告次要终点

研究者

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

DILEK YAZICIOGLU

Assoc Professor

Diskapi Teaching and Research Hospital

研究点 (1)

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