Comparison of continuous pericapsular nerve group block versus continuous fascia iliaca block in patients undergoing hip fracture surgery- a randomized double- blind study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To measure total fentanyl requirements in continuous pericapsular nerve group block versus continuous fascia iliaca block
研究概览
简要总结
Brief Summary:
The aim of the study is to compare the analgesic effect of continuous pericapsular nerve group block (cPENG) and continuous fascia iliaca block (cFIB) in hip fracture patients. The subject and the anaesthetist performing the block will be blinded to the type of block the subject receives. Patients aged 18 years or older with hip fracture scheduled for surgical treatment only under spinal anaesthesia will be assessed for eligibility to participate in the study. Patients with allergy to local anaesthesia, severe medical illness with end-organ damage, ASA physical status Grade III and IV will be excluded from the study trial.
The followings will be assessed: subject’s vitals and numerical rating pain scale before and after nerve block at different time points (15 minutes, 30 minutes and during positioning for spinal anaesthesia). Block success is assessed 30 minutes post nerve block procedure if the patient’s pain score on the numerical rating scale drops by 2 points. Ease of positioning patient for spinal anaesthesia is assessed by a grading score and additional fentanyl requirements needed for positioning is noted. Once the block is given, catheter is inserted in both groups and ropivacaine 0.2% at 5ml/hr infusion is started. All patient will receive paracetamol 1gm, 8hourly for 48 hours post spinal placement.
Patients are monitored post their surgery at regular intervals of 2,6,12,24 and 48 hours to assess their pain scores and to note the additional fentanyl requirements they might need during this time frame. Any breakthrough pain measured with numerical rating scale more than 4 will be treated with 0.5 mcg per kg fentanyl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status grade I and II patients 2)Greater than 18 years of age 3)Patients undergoing an operation for neck of femur, sub-capital and intertrochanteric fracture under spinal anaesthesia.
排除标准
- •Patient refusal 2)ASA physical status III and IV 3)Known allergy to local anesthetics 4)Local site infection 5)Severe kidney and liver disease 6)Severe cardiac illness (NYHA Class III and IV) 7)Pre-operative opioid tolerance 8)Intrathecal morphine receivers 9)Postoperative epidural infusion receivers.
结局指标
主要结局
To measure total fentanyl requirements in continuous pericapsular nerve group block versus continuous fascia iliaca block
时间窗: 48 hours post operative
次要结局
- To compare the following between two groups(1) To assess NRS pain scores at rest and at 15° leg elevation)