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临床试验/NCT05912101
NCT05912101进行中(未招募)不适用

Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery

Bozyaka Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
2
主要终点
Positional Pain in Unilateral Spinal Anesthesia

研究概览

简要总结

Hip fracture is a common cause of surgery, especially in elderly patients. Unilateral spinal anesthesia in hip fracture surgery can prevent the undesirable effects of spinal anesthesia due to sympathetic blockade.

However, severe pain in hip fracture patients limits the positioning required for unilateral spinal anesthesia. The sedation and analgesia required to position patients with fractured hip remains inferior may cause respiratory depression, hemodynamic instability or postoperative cognitive impairment, especially in elderly patients. Lower extremity peripheral blocks can be used preoperatively to minimize the use of sedatives that may be required during positioning and to provide effective and safe analgesia.

详细描述

In the study, one anesthesiologist (Anesthesiologist A) will perform the relevant peripheral blocks according to the groups to which the patients are randomized; the other anesthesiologist (Anesthesiologist B) will perform unilateral spinal anesthesia in all patients blinded to the peripheral blocks.

On the day of surgery, the patients will first be taken to the block application room and standard monitoring (ECG, pulse oximetry, noninvasive blood pressure) will be applied in the supine position. In the pre-block period, individual pain assessment will be performed with the Visual Analog Scale (VAS - 0 cm = no pain / 10 cm = unbearable pain) and recorded on the case report form. After the pain assessment, disinfection of the block area will be performed with 10% povidone iodine (Batidex) in accordance with surgical sterilization rules. After sterilization, the relevant peripheral block will be performed by Anesthesiologist A under USG guidance. Intermittent negative aspiration will be performed during all interventions to detect possible vascular puncture. All groups will receive 30 ml of local anesthetic solution containing 5 mcg/ml adrenaline and bupivacaine at 0.25% concentration.

Group 1 (PENG Block): Convex USG Probe (1-5 mHz) is placed transversely on SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.

Group 2 (Suprainguinal Fascia Iliaca Compartment Block) : Linear USG Probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.

Group 3 (3-1 Block) Linear USG Probe (7-13 mHz) is placed at the femoral fold and femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.

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 (Investigator, Outcomes Assessor)

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

  • 18 years and over
  • American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III
  • Fully oriented and able to cooperate
  • Consented to participate in the study by signing the informed consent form
  • Patients with hip fracture and planned unilateral surgery with spinal anesthesia

排除标准

  • Patients under 18 years of age
  • Refusal to participate
  • American Society of Anesthesiologists Physical Status Classification(ASA) IV-V
  • Non-cooperation
  • Coagulopathy or thrombocytopenia
  • Allergic to local anesthetics and analgesics
  • Patients with anatomical abnormalities or active infection at the points of application

结局指标

主要结局

Positional Pain in Unilateral Spinal Anesthesia

时间窗: 30 minutes after the block is performed

Pain in the pre-block period and during unilateral spinal anesthesia positioning after the block will be evaluated by VAS score.

次要结局

  • Undesirable Side Effects(Postoperative first 24-hour-period)
  • The Time Until First Opiod Requirement(Postoperative first 24-hour-period)
  • Postoperative First 24-hour-period Total Opioid Consumption(Postoperative first 24-hour-period)
  • Patient and Surgeon Satisfaction(Immediately after the surgery)
  • Postoperative Pain(Postoperative 2nd, 6th, 12th and 24th hours)
  • Position Quality in Unilateral Spinal Anesthesia(30 minutes after the block is performed)
  • The Necessity for Sedoanalgesia for Positional Pain in Unilateral Spinal Anesthesia(30 minutes after the block is performed)

研究者

发起方
Bozyaka Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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