跳至主要内容
临床试验/CTRI/2023/06/053932
CTRI/2023/06/053932尚未招募1/2 期

Randomized Comparative Study of Ultrasound Guided Pericapsular Nerve Group Block vs Femoral Nerve Block for postoperative analgesia in hip fracture surgery in Department of Anaesthesia, SMS Medical College, Jaipur.

Sawai Man Singh Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月25日最近更新:
适应症

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
3.To determine the difference in mean time of first rescue analgesia by using NRS and mean dose of analgesic required in 24 hours in both groups.

研究概览

简要总结

Hip fractures are regarded as a worldwide epidemic and a major public health concern inmany countries (1). Globally, hip fractures rank among the top 10 causes of disability (2). Hipfractures are a common orthopaedic emergency in the elderly, and is associated with significant mortality and morbidity. Surgical reduction and fixation are the definitive treatment in most patients (3).

The majority of hip fractures in the elderly population results from an inadvertent fall,whereas, it is more commonly caused due to a high energy trauma in the younger and adultpopulation

(4). Irrespective of the aetiology, hip fractures are a painful condition, and early pain relief and definitive management is of utmost importance, especially in the elderly population.

Pre-operative pain from hip fractures can be managed by several modalities. The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids,and peripheral nerve blocks (5). Oral or intravenous analgesics, particularly opioids can cause unwarranted sedation, nausea, vomiting, respiratory depression, and delirium. The elderly population have a significant risk of delirium due to their age, co-morbidities, alteredmetabolic functions and physiology, or due to the under or over treatment of pain (6, 7).

Peripheral nerve blocks have several advantages such as, adequate pain management in thepre- operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects (3, 8).

The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, andthe femoral nerve. Studies suggest that the anterior capsule of the hip joint is richlyinnervated by these nerves and is targeted to provide analgesia. Regional anaesthetic techniques such as Femoral Nerve Block (FNB), and Fascia Iliaca Block (FIB) are routinely used for effective peri-operative analgesia due to opioid sparing effects. But, these blockades only provide moderate analgesia as the obturator nerve is inadequately affected (3, 9).

 Ultrasound guidance improves visualization of anatomical structures, success rate, quality of sensory block, onset time, decreases dose of local anesthetics and complications.

The Femoral Nerve Block targets the lateral femoral cutaneous nerve, femoral nerve, and the obturator nerve (9). The Pericapsular Nerve Group Block targets the articular branches of obturator nerve, anterior obturator nerve, and the femoral nerve, and is found to be aneffective regional anaesthetic technique for hip fracture surgeries (10).

After thorough review, there are very few studies that compare the efficacy of ultrasound guided PENG vs FNB for postoperative analgesia in patients who underwent surgery for hip fracture using 20mL of 0.5% Ropivacaine.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patients undergoing elective surgery for hip fracture, with NRS >
  • •Patients consenting to participate.
  • •Adult patients aged 30-70 Years.
  • •Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.

排除标准

  • •Patients with psychiatric illness, anxious, agitated.
  • •Patients with peripheral sensorineural deficit.
  • •Patients allergic to local anesthetics.
  • •Patients with contraindications to regional anaesthesia.
  • •oPatients with suspected compartment syndrome in lower limbs.
  • •Patients on analgesia within 8 hours before performing nerve block.
  • •Block failure cases (If NRS score is not < 3 within 20 min of performing peripheral nerve block).

结局指标

主要结局

3.To determine the difference in mean time of first rescue analgesia by using NRS and mean dose of analgesic required in 24 hours in both groups.

时间窗: 1.To assess and compare pain by NRS at hourly intervals till 6hrs and two hourly intervals till 24 hrs postoperatively. | 2.To observe the change in NRS at one minute interval up to 20 minutes after administration of block, for positioning of patient for spinal anaesthesia. | 3.To determine the mean dose of analgesic required in 24 hours in both groups.

1.To assess and compare pain by NRS at different time intervals in the postoperative period in both the groups.

时间窗: 1.To assess and compare pain by NRS at hourly intervals till 6hrs and two hourly intervals till 24 hrs postoperatively. | 2.To observe the change in NRS at one minute interval up to 20 minutes after administration of block, for positioning of patient for spinal anaesthesia. | 3.To determine the mean dose of analgesic required in 24 hours in both groups.

2.To observe the change in NRS at one minute interval maximum up to 20 minutes after administration of block, until NRS less than 3 for positioning of patient for spinal anaesthesia.

时间窗: 1.To assess and compare pain by NRS at hourly intervals till 6hrs and two hourly intervals till 24 hrs postoperatively. | 2.To observe the change in NRS at one minute interval up to 20 minutes after administration of block, for positioning of patient for spinal anaesthesia. | 3.To determine the mean dose of analgesic required in 24 hours in both groups.

次要结局

  • 1.To asses quadriceps muscle strength using Oxford muscle strength grading.(2.To determine the change in the haemodynamic parameters (HR, SBP, DBP, MAP & SpO2) in both groups.)

研究者

申办方类型
Government medical college

研究点 (1)

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