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临床试验/NCT05660603
NCT05660603招募中不适用

Circum-Psoas Blocks Versus Combined Lumbar and Sacral Plexus Blocks for Sensory Level and Postoperative Analgesia Obtained in Hip Fracture Surgery

Zagazig University2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年12月20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
63
试验地点
2
主要终点
Assess change of Visual analogue scale (VAS)

研究概览

简要总结

Hip fracture (HF) is one of the major worldwide problems that constitute a significant mortality rate, ranging from 14- 36% in the first year after injury, and is associated with profound temporary and sometimes permanent impairment of independence and quality of life in the geriatric population. Surgical treatment is considered the best option for patients with hip fractures,s 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 analgesic 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 in enhanced recovery after surgery (ERAS).

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

To our knowledge, there is no study done to compare circum-psoas block versus the combined lumbar and sacral plexus blocks as pre-emptive analgesia in patients undergoing hip fracture surgery 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. Both the lumbar (L1-L4) and sacral (L4-S4) plexuses innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from 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.

Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. 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 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.

Hip fracture is a major worldwide public health problem in elderly patients aged 65 years and over with an incidence of more than 1.6 million worldwide each year. Furthermore, the total number is expected to exceed 6 million by 2050. Generally, early surgical repair within 48-72 hours after admission is recommended according to the treatment guideline, however, elderly patients with hip fractures commonly have several comorbidities, which make these patients more liable to a high risk of morbidity and mortality after surgery. Pain, both before and during the first 24 hours of surgery is usually reported as severe by most patients therefore, one of the keys to a patient's recovery following hip fracture surgery, is effective postoperative pain management. Recently, the concept of pain relief with multimodal analgesia and regional anesthesia plays a vital role in postoperative analgesia minimizing opioid consumption and reducing the time to early mobilization. Several regional anesthetic techniques have been recommended, including intrathecal morphine, patient-controlled epidural analgesia, and various peripheral nerve blocks techniques; however, to obtain complete sensory loss for hip fracture surgery, it's required to block the branches of both lumbar and sacral plexuses, although there remains no single technique that reliably acquires this. Moreover, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for hip fracture surgery.

The ultrasound-guided lumbar plexus block results in the blockade of the FN, LFCN, and obturator nerve while the sacral plexus block results in the blockade of the sciatic nerve, superior and inferior gluteal nerves, posterior cutaneous nerve of the thigh, and the inferior hypogastric plexus. Thus, the combination of lumbar plexus and sacral plexus blocks results in complete analgesia of the ipsilateral lower limb in the perioperative period.

Circum-psoas blocks is a new sonar-guided fascial block technique proposed by Huili et al., where the two main branches of the lumbar plexus (FN and LFCN) can be blocked by local anesthetic (LA) injection posterior to transversalis fascia (TF) and around the anterolateral edge of psoas muscle (PM) just cranial to iliac crest. Furthermore, cranial spread along TF may lead to a lower thoracic paravertebral block through the medial arcuate ligament. On the other hand, the obturator nerve and lumbosacral trunk could be blocked if the LA is injected at the level of L5/S1 into the retro-psoas space and around the posterior edge of PM.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient acceptance.
  • BMI ≤ 30 kg/m2
  • ASA I-III.
  • First unilateral surgery for hip fracture including femoral neck, intertrochanteric or subtrochanteric fracture.
  • Patient with planned hip fracture surgery within 24-72 hours under general anesthesia.

排除标准

  • Multiple trauma, multiple fractures, or pathological fractures
  • Prosthetic fracture or usage of bone-cement fixation in the surgery.
  • Scheduled for bilateral hip fracture surgery.
  • Pre-existing neurological deficit in the lower extremity
  • Contraindication for peripheral nerve block (infection at the site of needle insertion, coagulopathy, allergy to local anesthetics used)
  • History of chronic pain and taking analgesics
  • History of cognitive dysfunction or mental illness

结局指标

主要结局

Assess change of Visual analogue scale (VAS)

时间窗: at 30 minutes, 2 hours, 4, 6,12, 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 hour postoperatively)
  • Assess sensory block levels(at 2 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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