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临床试验/NCT07153575
NCT07153575已完成不适用

Comparison of the Postoperative Analgesic Effectiveness of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in Hip Arthroplasty

Balikesir University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月12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
发起方
入组人数
60
试验地点
2
主要终点
To compare the postoperative analgesic efficacy of SFIB and PENG block

研究概览

简要总结

The goal of this clinical trial is to compare the analgesic effectiveness of two blocks in hip arthroplasty. The main question it aims to answer is

-Which block is more efficient? Researchers will compare the suprainguinal fascia iliaca block with the pericapsular nerve group block.

Participants will be randomized, and one of the blocks will be applied.

详细描述

Postoperative pain and analgesia in hip surgery is an important issue for early mobilization and length of hospital stay. The patient population is usually elderly. Prolonged hospital stay may cause thromboembolic complications due to delayed mobilization, psychiatric conditions such as delirium, and many undesirable conditions caused by pain such as chronicisation of acute pain. There are neuraxial analgesia, regional analgesia and multimodal analgesia regimens that are used together to prevent postoperative pain and to prevent these undesirable conditions caused by pain. Suprainguinal fascia iliaca block and pericapsular nerve group blocks are two of those. With performing these blocks, we will obtain postoperative analgesia and avoid postoperative complications.

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)

盲法说明

The anesthetist performing the block was aware of group allocation. Patients and the anesthetist assessing postoperative outcomes were blinded to group allocation.

入排标准

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

入选标准

  • Volunteer patients undergoing hip arthroplasty
  • Voluntary patient to undergo elective operation under regional anaesthesia
  • ASA I-II-III
  • BMI≤35 kg/m²

排除标准

  • Obstacles to the application of regional anaesthesia
  • Local Anaesthetic Allergy
  • Coagulopathy
  • Psychiatric disorders and medication
  • Hematological/Oncological disease
  • Severe organ failure
  • Multiple bone fractures
  • Alcohol/Drug addiction
  • Used analgesic medication up to 12 hours before surgery
  • Infection at the Block Application Site
  • Mental Deficiency
  • Morbidly obese patients

研究组 & 干预措施

Suprainguinal fascia iliaca block

Active Comparator

The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

干预措施: suprainguinal fascia iliaca block (Procedure)

Pericapsular nerve group block

Active Comparator

In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the articular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.

干预措施: Pericapsular nerve group (PENG) block (Procedure)

结局指标

主要结局

To compare the postoperative analgesic efficacy of SFIB and PENG block

时间窗: 24 hours

Calculating total morphine consumption over 24 hours in patients by using patient controlled analgesia pump.

次要结局

  • Postoperative analgesia scores(24 hours)
  • Assessment of nausea and vomiting incidence(24 hours)
  • Postoperative analgesia scores(24 hours)
  • Assessment of nausea and vomiting incidence(24 hours)

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Ugun

Assistant Professor, MD

Balikesir University

研究点 (2)

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