A randomized comparative study to evaluate pre operative and post operative analgesic effect of ultrasound guided pericapsular nerve group block Vs fascia iliaca block in patients undergoing elective hip fracture surgery in Department of Anaesthesiology, SMS Medical College and Attached Hospitals, Jaipur
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To assess and compare pain by NRS at
研究概览
简要总结
Hip fractures are considered as a widespread problem on a global scale and significant public health issue in numerous nations.On a worldwide scale, hip fractures are listed as one of the top 10 causes of disability.Hip fractures frequently occur as urgent orthoedic incidents in the elderly population,and they are linked to notably high rates of morbidity and mortality.In most cases,surgical reduction and fixation represent definitive treatment approach.
Irrespective of the type of surgical procedure, hip surgeries cause significant postoperative pain which can result in further complications and patient dissatisfaction. Indeed, the need for optimal analgesia cannot be underestimated for hip surgeries wherein the patient clientele is mostly elderly and the joint is primarily involved in patient mobility.
The 2011 NICE guidelines for management of hip fractures recommend the use of IV paracetamol, opioids, and peripheral nerve blocks . 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, altered metabolic functions and physiology, or due to the under or over treatment of pain
Regional anesthetic techniques are increasingly being used to provide better pain control. Peripheral nerve blocks have several advantages such as, adequate pain management in the pre-operative and post-operative time, facilitate early mobilization, and reduction in the dose of opioids required and their related side effects .
The femoral nerve block block and the fascia iliaca compartment block (FICB) are commonly used analgesic techniques in hip surgeries. Both blocks have equivalent analgesic efficacy.
However, a disadvantage of the fascia iliaca block is the associated motor weakness of the surgical limb which can delay recovery and patient discharge
The hip joint is innervated by branches of the obturator nerve, anterior obturator nerve, and the femoral nerve. Studies suggest that the anterior capsule of the hip joint is richly innervated by these nerves and is targeted to provide analgesia.
Recently, Girón-Arango (9), have described a novel anaesthetic modality named the pericapsular nerve group (PENG) block which anesthetizes the femoral nerve, obturator nerve, and the accessory obturator nerve while sparing the motor components. Studies have shown that the PENG block is efficient in providing postoperative analgesia in patients undergoing hip surgeries with preservation of quadriceps muscle strength
Ultrasound guidance improves visualization of anatomical structures, success rate, quality of sensory block, onset time, decreases dose of local anesthetics and complications.
There are very few studies that compare the efficacy of PENG vs FIB for postoperative analgesia in patients who underwent surgery for hip fracture.
In this study we aim to compare the preoperative and postoperative analgesic efficacy of ultrasound guided Pericapsular Nerve Group Block vs Fascia iliaca Block In Patients Undergoing Hip Fracture Surgery
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
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective surgery for hip fracture.
- •Patient having baseline NRS more than 7
- •Patients consenting to participate.
- •Adult patients.
- •5 Patients belonging to American Society of Anesthesiologists (ASA) grade I, II and III.
排除标准
- •1.Patients with psychiatric illness, anxious, agitated.
- •2.Patients with peripheral sensorineural deficit.
- •3.Patients allergic to local anesthetics.
- •4.Patients with contraindications to regional anaesthesia.
- •Patients with suspected compartment syndrome in lower limbs.
- •6.Patients on analgesia within 8 hours before performing nerve block.
- •Block failure cases -If NRS score is not less than 3 within 20 min of performing peripheral nerve block.
结局指标
主要结局
1.To assess and compare pain by NRS at
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
different time intervals after administration of block.
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
minute interval maximum up to 20 minutes
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
after administration of block, until NRS less
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
than 3 for positioning of patient for spinal
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
anaesthesia.
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
3.To determine the difference in mean time
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
mean dose of analgesic required in 24 hours
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
of first rescue analgesia by using NRS and
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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.
in both groups.
时间窗: 1.To assess and compare pain by | NRS at 30min,1st,2nd,4th and 6th hr followed by every 6th hourly till 24 hours after administering block. | 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
- To determine the change in the hemodynamic parameters (HR, SBP, DBP, MAP and(SpO2) in both groups.)
- 2. To assess and compare patient satisfaction by using three point likert rating scale(between both the groups)
- To observe side effect or complication, if any(in pre-operative,peri-operative and post-operative period)