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临床试验/NCT05286125
NCT05286125招募中不适用

Erector Spinae Plane Block Versus Oblique Subcostal Transverses Abdominis Plane Block for Controlling Postoperative Pain After Umbilical Hernia Repair

Zagazig University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Postoperative analgesic requirements

研究概览

简要总结

Comparing the impact of bilateral erector spinae plane block and transverse abdominis plane block on improving quality of pain management after umbilical hernia repair.

详细描述

Postoperative pain is an important problem after umbilical hernia repair which has negative effects on patient's hemodynamics and cause delayed ambulation resulting in prolonged duration of hospital stay and poor patient satisfaction.

Multiple analgesic strategies have been proposed including Non steroidal anti-inflammatory drugs (NSAIDs), opioids, epidural analgesia. Each of them has its limitations.

Ultra¬sound guided regional anesthesia techniques for abdominal wall can be effective components of multimodal postoperative analgesia with limited side-effects Erector spinae plane (ESP) block is a promising para-spinal bock that can achieve both visceral and somatic abdominal analgesia if the injection was performed at a lower thoracic level. Transverse abdominis plane (TAP) block which is considered a peripheral nerve block that is aimed at anesthetizing nerves supplying the anterior abdominal wall.

We will compare between erector spinae plane block and transverse abdominis plane block for controlling postoperative pain after umbilical hernia repair.

Patients will be allocated randomly into two equal groups by a computer-generated randomization table Group (E) (n=26): Patients will receive erector spinae plane (ESP) block after completion of surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients scheduled for elective umbilical hernia repair.
  • •Patient acceptance.
  • •Patient's age 21 - 60 years.
  • •Patients with American Society of Anesthesiologists (ASA) physical status I, II.
  • •BMI 25 - 30 kg m-2.

排除标准

  • •Uncooperative patients and patients with psychological problems.
  • •Patients with liver or renal impairment.
  • •Patients with contraindication to regional anesthesia.
  • •Patients with history of allergy to drug used in the study.
  • •Patients with chronic pain.

研究组 & 干预措施

erector spinae plane (ESP) block group ( (E) group)

Active Comparator

Under aseptic conditions, a high frequency linear transducer will be placed on the spinous process at T8 level on the parasagittal plane and then slid 2.5-3 cm laterally to visualize the transverse process and erector spinae muscle.

干预措施: erector spinae plane (ESP) block (Procedure)

oblique subcostal transverse abdominis plane (TAP) block ( (T) group) )

Active Comparator

Under aseptic conditions, the probe will be initially placed below the xyphoid process to view the linea alba, then directed obliquely down the costal margin while keeping the rectus abdominis muscle in view. The transverse abdominis muscle come into view below the rectus abdominis muscle. The probe will be advanced further until the semilunaris is viewed.

干预措施: oblique subcostal transverse abdominis plane (TAP) block (Procedure)

结局指标

主要结局

Postoperative analgesic requirements

时间窗: 24 hours postoperative

measuring the total doses of analgesic required to relieve the pain

次要结局

  • Postoperative heart rate changes(24 hours postoperative)
  • Postoperative pain severity using Numeric Rating Scale(24 hours postoperative)
  • Postoperative blood pressure changes(24 hours postoperative)
  • Postoperative pain severity using Visual Analogue scale(24 hours postoperative)
  • Incidence of postoperative side effects(24 hours postoperative)
  • Duration of postoperative hospital stay(24 hours postoperative)
  • Postoperative pain severity using Verbal Rating Scale(24 hours postoperative)

研究者

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

Michael Adel Shaker

lecturer of anaesthesia and intensive care

Zagazig University

研究点 (1)

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