跳至主要内容
临床试验/NCT05030688
NCT05030688撤回不适用

Comparison of the Effect of Ultrasound-guided Fascia Iliaca Compartment Block and PENG Block on Postoperative Analgesia Management in Patients Undergoing Hip Arthroplasty: A Multicentric, Randomized, Prospective Study.

Medipol University3 个研究点 分布在 1 个国家开始时间: 2021年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
3
主要终点
Global recovery scoring system (patient satisfaction scale)

研究概览

简要总结

Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joint. Patients may complain severe pain due to the surgical trauma and the prosthesis. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Because of the increasing use of ultrasound (US) in anesthesia practice, US-guided nerve blocks are widely used. One of the most used methods in the management of analgesia after hip surgery is the fascia iliaca compartment block (FICB). Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed to block the femoral nerve and the accessory obturatory nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. This prospective, multicenter study aimed to compare the efficacy of PENG block and FICB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare global recovery scores, and our secondary aim is to evaluate postoperative opioid consumption, pain scores (Numerical Rating Scale-NRS), and side effects (allergic reaction, nausea, vomiting, etc.) related with opioid use.

详细描述

Hip arthroplasty is one of the most common orthopedic procedures especially in elderly patients due to deformation of joint. Patients may complain severe pain due to the surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation and respiratory depression. Regional anesthesia methods may be performed to reduce opioid consumption and opioid-related side effects. The hip joint consists of the femoral head and the acetabulum. Sensory innervation of the hip joint is provided by the femoral nerve, obturator nerve, articular branches of the sciatic nerve, and superior gluteal nerve. Skin innervation of the lateral femur is provided by the lateral cutaneous femoral nerve. The upper anterior part of the thigh is innervated by the genitofemoral and ilioinguinal nerves. These nerves originate from the lumbar and sacral plexus. The innervation of the hip joint is complex, and the selection of the blocking technique is important after these operations.

Because of the increasing use of ultrasound (US) in anesthesia practice, US-guided nerve blocks are widely used. One of the most used methods in the management of analgesia after hip surgery is the fascia iliaca compartment block (FICB). FICB was first described in 1989 by Dalens et al. defined by. It is a popular regional anesthetic technique for surgical procedures involving the hip joint and femur. Since the local anesthetic agent is injected proximally under the fascia ilica, FICB can be considered as the anterior approach of the lumbar plexus blockade. It blocks the femoral nerve, obturator nerve, and lateral cutaneous femoral nerve. There are studies in the literature reporting that it provides effective analgesia after hip surgery.

Pericapsular nerve group block (PENG block) is a novel fascial block defined by Arango et al. In this block, it is aimed to block the femoral nerve and the accessory obturatory nerve by injecting local anesthetic between the pubic ramus and the psoas tendon. By blocking these nerves, anterior hip analgesia is provided. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that total hip analgesia can be provided by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves when high volume is applied. Studies evaluating PENG block efficacy are limited in the literature. There is a study comparing PENG block and femoral nerve block, but there is no study comparing it with FICB yet.

This prospective, multicenter study aimed to compare the efficacy of PENG block and FICB for postoperative analgesia management in patients undergoing hip arthroplasty with a prosthesis. Our primary aim is to compare global recovery scores, and our secondary aim is to evaluate postoperative opioid consumption, pain scores (Numerical Rating Scale-NRS), and side effects (allergic reaction, nausea, vomiting, etc.) related with opioid use.

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, Outcomes Assessor)

盲法说明

The patient, and the outcomes assessor who performs postoperative pain evaluation will not know the group.

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ASA classification I-III, aged 50-80 years, who were scheduled for hip arthroplasty under general anesthesia, will be included in the study.

排除标准

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • patients who do not accept the procedure

结局指标

主要结局

Global recovery scoring system (patient satisfaction scale)

时间窗: Change from baseline scores at postoperative 1, 2, 4, 8, 16, and 24 hours

This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions).

次要结局

  • Pain scores (Numerical Rating Scale-NRS)(Postoperative 1, 2, 4, 8, 16, and 24 hours)
  • Opioid consumption(Postoperative 1, 2, 4, 8, 16, and 24 hours)

研究者

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

Bahadir Ciftci

Primary researcher

Medipol University

研究点 (3)

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