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临床试验/NCT05788458
NCT05788458已完成4 期

Effect of Bupivacaine Concentration on Ultrasound Guided Pericapsular Group Nerve Block Efficacy in Hip Surgery Patients: A Randomized Controlled Double Blinded Trial

Benha University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
135
试验地点
1
主要终点
NRS at rest and on passive 15° limb lifting, EOSP.

研究概览

简要总结

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain.The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG).

详细描述

Fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. A hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. Early surgery within 48 h of fracture has shown to decrease the complication and mortality rates.

Spinal anaesthesia is the most common mode of anaesthesia used to fix these fractures. Extreme pain due to fracture does not allow ideal positioning for these procedures. and hence a problem to access the subarachnoid space. Inadequate postoperative analgesia can restrict the limb mobility thereby delaying recovery along with increased consumption of opioids.

Effective perioperative analgesia that reduces the requirement of opioids and its adverse effects is essential in this population.

The anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (AON) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by Peri-capsular nerve group (PENG) .

PNB with lower volume and higher concentration of local anesthetic was more efficacious than higher volumes and lower concentrations of local anesthetic of equivalent dose.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (ASA )classes I and II
  • patients of either sex
  • above the age of 18 who will undergo hip surgeries( (Dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under SA with an expected duration of 2.5 hours).

排除标准

  • patient's refusal to participate
  • any contraindications to SA or peripheral nerve blocks
  • history of ischemic heart disease
  • patients on opioids for chronic pain
  • patients with significant cognitive impairment.
  • Patients who have surgery on the hip or spine within 3 months or have no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support

研究组 & 干预措施

Group A

Active Comparator

will receive 20 ml of 0.25 % bupivacaine

干预措施: Bupivacain (Drug)

Group B

Active Comparator

will receive 20 ml of 0.375 % bupivacaine.

干预措施: Bupivacain (Drug)

Group C

Active Comparator

will receive 20 ml of 0.5 % bupivacaine.

干预措施: Bupivacain (Drug)

结局指标

主要结局

NRS at rest and on passive 15° limb lifting, EOSP.

时间窗: 30 minutes after the block

From 0 to 10 (0 no pain , 10 very sever pain)

次要结局

  • NRS over 24 hours(2,4,8,16,24 hours postoperative)
  • Quality of recovery score (QoR-15)(at 24 hours postoperative)
  • Amount of morphine intake.(24 hours postoperative)

研究者

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

Fatma Ahmed Abdel Fatah

lecturer

Benha University

研究点 (1)

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