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临床试验/NCT05556759
NCT05556759招募中不适用

Anterior Iliopsoas Muscle Space Block Versus Supra-Iliac Anterior Quadratus Lumborum Block for Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
2
主要终点
changes in Visual analogue scale (VAS)score

研究概览

简要总结

Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly, however, it is associated with moderate to severe postoperative pain.

Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesia techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components of enhanced recovery after surgery (ERAS).

Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.

Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA under general anesthesia

详细描述

The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from the superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.

The lumbar plexus nerves, including the femoral, obturator, and lateral femoral cutaneous nerves, lie within the psoas major (PM) muscle. These nerves then exit the PM to lie within the iliopsoas compartment, between the iliacus and PM muscles. The sacral plexus is located also in the caudal extension of this anatomical space. The iliacus and psoas muscles are wrapped by the fascia iliaca. The fascia iliaca fuses superiorly with the anterior thoracolumbar fascia (transversalis fascia) that wrapped both the quadratus lumborum (QL) and the psoas muscles.

Total hip arthroplasty (THA) is a common orthopedic surgical procedure that has been successfully utilized to treat hip fractures since 1960 [4] as well, it is considered the treatment of choice for osteoarthritis of the hip joint. Both implants' types cemented and uncemented can provide good fixation, resulting in favorable long-term outcomes [5]. One of the keys to a patient's recovery following THA surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioids consumption and decreasing the time to mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, intrathecal morphine, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.

The ultrasound-guided (QL) block is a regional anesthetic technique that was initially proposed as an analgesic modality for abdominal surgery through many approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block The anterior QL block has been performed at the L3-L4 level also been used in hip surgery case reports.

A supra-iliac approach to the anterior QL block that is performed at a lower level than traditional anterior QL block approaches is considered a new approach discovered by Elsharkawy et al., and they found that a single injection between QL and Psoas muscle at the level of L5, successfully block the lumbar plexus and provide analgesia in patients undergoing total hip arthroplasty.

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

double-blinded(participants and outcome assessors)

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

  • Patient acceptance.
  • Age 50-80 years old.
  • BMI ≤ 30 kg/m2
  • ASA I - III.
  • Elective total hip arthroplasty under general anesthesia.

排除标准

  • History of allergy to the LA agents used in this study
  • Skin lesion at the needle insertion site,
  • Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
  • Pre-existing neurological deficit in the lower extremity
  • History of chronic pain and taking analgesics
  • History of cognitive dysfunction or mental illness

结局指标

主要结局

changes in Visual analogue scale (VAS)score

时间窗: measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively

On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain

次要结局

  • Total dose of rescue analgesia(in the first 24 hours postoperatively)

研究者

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

Shereen Elsayed Abd Ellatif

associate professor of anesthesia and surgical intensive care

Zagazig University

研究点 (2)

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