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临床试验/NCT05351203
NCT05351203已完成不适用

Ultrasound Guide Bilateral Erector Spinae Block Versus Caudal Epidural Analgesia for Perioperative Analgesia in Lumbar Spine Surgeries:Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月8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
50
试验地点
1
主要终点
time to first analgesia request

研究概览

简要总结

Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in 2016Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.

The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during peri-operative period.

Objectives:

  • To assess the duration of analgesia in both groups and time to rescue analgesia .
  • To assess Visual analogue scale (VAS) score in both groups.
  • To assess complications of both groups

详细描述

This is a randomized controlled study designed to include 50 patients aged from 18 to 65 years old undergoing lumbar spine surgeries.

fifty patients meeting the inclusion criteria will be randomly assigned into two equal groups: Group A(n=25): caudal epidural group. Group B(n=25): bilateral ultrasound guided Erector spinae block group.

All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests .

● Operating Room preparation & Equipment: The ultrasound used will be SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 MHz linear array).

Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

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
是

入选标准

  • •Patients undergoing Lumbar spine surgery (L1-L5).
  • •American society of anesthesiologists classification (ASA) I and II.

排除标准

  • •Patient's refusal.
  • •Bleeding disorders (platelets count < 150,000; International normalized ratio >1.5; PC< 60%) and coagulopathies.
  • •Skin lesion, wounds or infection at the injection site.
  • •Known allergy to local anesthetic drugs.
  • •Chronic opioid or NSAIDS users.
  • •Patients with pre-operative opioid consumption

研究组 & 干预措施

Erector spinae group

Experimental

● The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound) will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 30 mL of 0.25% bupivacaine will be injected. The procedure will be repeated following the same steps on the other side.

干预措施: Erector spinae block (Procedure)

caudal epidural group

Active Comparator

the patient will be positioned in prone position, sterilized from the iliac crest margin to the lower buttock by betadine three times and will be covered by sterile drapes exposing the sacral area. Sacral horns will be palpated and sacral hiatus and epidural area will be determined at S4-S5 level through the ultrasound linear transducer probe that is covered in sterile plastic bag . Short axis (transverse) is used first to identify the two sacral cornua as two hyperechoic reverse U-shaped structure "Frog sign" and the sacrococcygeal ligament in between and epidural space beneath. An 18-gauge epidural needle (length 90 mm) is used for direct puncture of sacrococcygeal membrane out of plane then the probe is rotated to long axis (longitudinal) and the needle is seen in plane in the epidural space. Injection of 30 ml 0.125% bupivacaine will expand the epidural space.

干预措施: caudal block (Procedure)

结局指标

主要结局

time to first analgesia request

时间窗: 12 hours

postoperative first rescue analgesia time

次要结局

  • presence of any complications(24 hours)
  • Mean arterial blood pressure(evey 10 minutes intraoperative till end of surgery (up to 2 hours))
  • cumulative 24 hours opioid consumption(24 hours)
  • VAS score(at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively)
  • Heart rate(every 10 minutes intraoperative till end of surgery(up to 2 hours))

研究者

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

Abd elmoneim Adel Abd elmoneim

clinical professor

Cairo University

研究点 (1)

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