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临床试验/NCT06321718
NCT06321718已完成不适用

Comparison Between Pericapsular Nerve Group (PENG) Block With Lateral Femoral Cutaneous Nerve Block and Supra Inguinal Fascia Iliaca Compartment Block (S FICB) for Traumatic Hip Fixation Surgeries: a Randomized Controlled Trial

Assiut University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
recording time for "return of full muscle power"

研究概览

简要总结

This study aims to assess the efficacy of PENG block performed with LFCN block in controlling postoperative pain and promoting motor function recovery and to compare its effectiveness with S-FICB.

详细描述

96 Patients will be assessed thoroughly for history (to exclude previous medical history, previous anesthesia, with/without perioperative complications, smoking status, cardiorespiratory disorders or bleeding disorders), examination (for the full primary and secondary trauma survey to exclude any coexisting trauma that threatens patient life, laboratory (for CBC, bleeding tendencies, serology, kidney dysfunction and availability of blood transfusion) and radiological (for cardiac assessment, and exclusion of other trauma). ASA score then to be determined. Full monitoring of the patient will be recorded, basically, HR, ECG, SpO2, NIBP, EtCO2, temperature. Peripheral vein cannula will be secured and the fluids will be infused as 10- 15ml/kg before induction of anesthesia. Choice of type of anesthesia will be established according to every individual patient, but spinal anesthesia will be preferred over general anesthesia. The block will be administered under supervision of the supervisor senior staff before induction of anesthesia. Type of the block will be randomly assigned into two groups according to website computer program randomization program to distribute cases into two groups using their order number:

  1. Group (A) will receive PENG + LFCN block: The low-frequency curvilinear probe (3-5 MHz) of ultrasound (GE Logiq e, GE Health care, USA) will be placed in a transverse plane over the anterior inferior iliac spine (AIIS) and aligned with the pubic ramus by rotating the probe counterclockwise to obtain a hyper-echoic bright line, which is the iliopubic eminence (IPE). In this view, the iliopsoas muscle and psoas tendon, the femoral artery, and pectineus muscle can be observed. Using the in-plane injection technique, a 22G, 80 mm insulated block needle was inserted in a lateral-to-medial direction, and the tip will then be placed between the psoas tendon anteriorly and the pubic ramus posteriorly. After no blood was drawn back, the LA (20 ml, 0.25% bupivacaine) will be injected to get an image of the psoas tendon uplifted. After the PENG block is performed, a high-frequency linear probe (6-12 MHz) will be placed on the inguinal ligament to get a short-axial view of femoral artery, then the probe is moved laterally to identify the sartorius muscle, the tail of the probe will be positioned toward the anterior superior iliac spine to observe the LFCN covered by fascia between sartorius and tensor fascia lata. After no blood can be withdrawn back, the LA (10 ml, 0.25% bupivacaine) will be injected following negative aspiration
  2. The second group (B): S-FICB: A high-frequency linear probe (6-12 MHz) of ultrasound (GE Logiq e, GE Healthcare, USA) will be used. The probe is placed adjacent to the inguinal ligament with its long axis parallel to the ligament. After the femoral artery and the femoral nerve will be observed, the probe will be moved laterally to identify the sartorius muscle and placing it at the center of the screen. Then the probe will be moved cephalically to the anterior superior iliac spine (ASIS) until the image of the sartorius muscle will disappear, and the medial side of ASIS was identifed as the iliacus muscle. Next, by rotating the medial end of the ultrasound probe toward the umbilicus, the ASIS, iliac bone, and abdominal muscles will be observed on the screen. Using the in-plane technique, a 22G, 80 mm insulated block needle will be inserted in a lateral-to-medial direction. When the needle tip will penetrate below the fascia iliacus, the LA (40 ml, 0.25% bupivacaine) will be injected following negative aspiration to obtain an image showing the LA spread between the iliacus muscle and the fascia iliacus.

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 (Participant)

盲法说明

Through website computer program randomization program to distribute cases into two groups using their order number

入排标准

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

入选标准

  • All hip trauma patients ≥ 18 years' old
  • ASA class I, II, and III
  • Solitary hip fracture

排除标准

  • Neurological disturbance either baseline or traumatic brain injury
  • Contraindications for regional anesthesia as bleeding disorders, infection at site of injection, or hypersensitivity to the used local anesthetics.
  • Patient refusal.
  • Massive poly trauma.
  • Uncooperative patient

研究组 & 干预措施

2. group (B)

Experimental

will receive S-FICB

1. Group (A)

Experimental

will receive PENG + LFCN block

结局指标

主要结局

recording time for "return of full muscle power"

时间窗: at hour 0, 2 hours, 4 hours, 6 hours, 12 hours after procedure

duration between the end of surgery and the first time the patient was able to move his operated leg. The full power return will be defined as pre-operative muscle power according to manual muscle testing scale (MRC)/ Muscle Power Scale as following: Score Description 0 No contraction 1. Flicker or trace of contraction 2. Active movement, with gravity eliminated 3. Active movement against gravity 4. Active movement against gravity and resistance 5. Normal power

次要结局

  • • Static and dynamic pain scores.(at 6 hours, 24 hours, and 48 hours.)
  • postoperative nausea and vomiting (PONV) scale(at 48 hours.)
  • • The number of rescue analgesia(24 hours)
  • • The degree of hip flexion on the operative side(at 6 hours, 24 hours, and 48 hours.)

研究者

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

Ayman Abd El-Khalek Mohammed Glala

principal investigator

Assiut University

研究点 (2)

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