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临床试验/NCT04899388
NCT04899388已完成2 期

Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block as Postoperative Analgesia in Hip Surgeries: A Randomized Controlled Trial

Zagazig University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
69
试验地点
1
主要终点
the time to first postoperative rescue analgesia

研究概览

简要总结

assess and compare the efficacy of pericapsular nerve group block wersus lumber erector spinae plane block in reducing postoperative pain within the first 24 hours after hip surgeries.

详细描述

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 3groups each one containing 23 patients ,PENG group (n =23 ): The patients will receive Pericapsular Nerve Group Block (PENG Block) before positioning for spinal anesthesia.

ESPS group E (n =23 ): The patients will receive Lumbar Erector Spinae Plane Block before positioning for spinal anesthesia.

Control group C(n =23 ): patients received spinal anesthesia without any block.

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, Care Provider)

盲法说明

douple

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 65 to 75 years old. American Society of anesthesiologists physical status II and III. Body mass index of 25 to 30 kg/m2.

排除标准

  • Altered mental status. History of trauma or multiple fractures Uncontrolled hypertension and or diabetes. Coagulopathy. Preexisting advanced kidney, liver, or heart disease. Allergies or contraindications to the study drugs. Chronic use of opioids or corticosteroids.

研究组 & 干预措施

PENG

Active Comparator

the patients lied in the supine position. The probe was originally placed in a transverse plane above the anterior superior iliac spine in the ipsilateral surgical site and then counterclockwise rotated about 45 degrees to line up with the pubic ramus. The iliopubic eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle were all visible in this view. By an in-plane technique, from lateral to medial, a 22-gauge, 80-mm needle was placed in the musculofascial plane between both the psoas tendon anteriorly and the pubic ramus posteriorly .The local anesthetic medication was delivered after negative aspiration while looking out for proper fluid distribution for a total volume of 20 mL of Bupivacaine 0.25%

干预措施: Pericapsular Nerve Block (Procedure)

ESPB

Active Comparator

TThe patient was positioned at the lateral decubitus posture in the ipsilateral surgical site. The convex USG transducer was moved from the midline to the side of the operation and positioned 4-6 cm lateral to the L3 spinous process in a longitudinal parasagittal plane. The needle was advanced using the in-plane superior-to-inferior approach. The needle was advanced with the tip introduced up to the plane anterior to the "erector spinae muscle" and the posterior surface of the L3 transverse process. 0.5-1 ml of normal saline was administered for hydrodissection and to ensure proper placement .If there was any resistance during administering local anesthesia, the needle was modified by drawing it back a few millimeters. the prepared local anesthetic solution 20 ml bupivacaine 0.25 % was delivered through the point between both the transverse process and the erector spinae muscle

干预措施: Lumbar Erector Spinae Plane Block (Procedure)

control

Placebo Comparator

patients received spinal anesthesia without any block

干预措施: Fentanyl (Drug)

结局指标

主要结局

the time to first postoperative rescue analgesia

时间窗: 24 hours postoperative

the time to ask for the first postoperative analgesia (morphine) when the patient is reporting NRS ≥ 3

次要结局

  • Block performance time (min)(immediately before surgery)
  • adverse effects(24 hours postoperative)
  • Patient satisfaction(24 hours postoperative)
  • onset of sensory block(after the block)
  • pain intensity(30 minutes after the end of surgery ,3,6,12 hours postoperative.)
  • The total dose of rescue analgesia(24 hours postoperative)

研究者

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

Marwa Mohamed Medhat

lecture of anesthesia and surgical intensive care (Principal Investigator)

Zagazig University

研究点 (1)

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