Comparing the postoperative analgesic effect between the ultrasound guided Pericapsular Nerve Group PENG block and Fascia Iliaca Compartment Block FICB in intertrochanteric hip fracture surgeries
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Esic Medical College and Hospital
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare postoperative analgesic effect between PENG (pericapsular nerve
概览
简要总结
This randomized double blinded clinical trial will be conducted at ESIC Medical College and Hospital Chennai, after approval from the institutional ethics committee. Informed written consent will be obtained from all the participants of the study. All the patients scheduled for elective intertrochanteric hip fracture surgeries between the age group 40 to 70 years of either sex belonging to ASA 1,2 and 3 will be included in the study. On the day of surgery, spinal anaesthesia will be given for the surgery as per standard institutional protocol. Randomization will be done by a computer-generated table of random numbers. The allocation list will be generated and concealed in sealed envelopes. One envelope will be opened for each eligible candidate and the patient will be allocated to one of the two groups. The patient and the principal investigator will be blinded to this study. An Anaesthesiologist trained in these blocks will be performing the procedure. After surgery, under sterile aseptic precautions, patients in the Group A will receive an ultrasound guided pericapsular nerve group block using 0.25 percentage bupivacaine 28 ml and 8 mg of dexamethasone 2 ml. Patients in the Group B will receive an ultrasound guided Fascia Iliac compartment block using 0.25 percentage bupivacaine 28 ml, and 8 mg of dexamethasone 2 ml. Once the regional block is complete the patient will be shifted to the PACU post anaesthesia care unit for further observation. The study will start from the time the patient is shifted to PACU. The postoperative analgesia effect and other parameters such as heart rate, blood pressure, oxygen saturation spo2, first time of rescue analgesia, total opioid consumption, adverse effects, degree of range of motion by HARRIS HIP SCORE at 0min, 15 min,30min,1 hour,2 hrs, 4hrs,8hrs,12 hrs and 24hrs after blockade. The injection of tramadol 1mg per kg mg intravenous sos will be considered as rescue analgesia if Visual Analogue Scale more than 4. Nausea, which is one of the most common side effects of tramadol, will be treated with injection Ondansetron 0.1 mg per kg intravenous.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age 40 to 70 years old who underwent isolated intertrochanteric fracture surgeries provided written consent Both sex Belonging to ASA 1 ASA 2 and 3 physical status.
排除标准
- •Patient refusal for PENG or FICB Patients who are not cooperative Revision surgeries Known allergies to local anaesthetics Infection at the site of injection ASA physical status of 4 and above.
结局指标
主要结局
To compare postoperative analgesic effect between PENG (pericapsular nerve
时间窗: 30 minutes to 24 hrs
group block) and FICB (fascia iliaca compartment block) in intertrochanteric hip
时间窗: 30 minutes to 24 hrs
fracture surgeries via the visual analog scale (VAS)
时间窗: 30 minutes to 24 hrs
次要结局
- To compare the time of first request of rescue analgesia between pericapsular nerve group block(and fascia iliac compartment block.)
研究者
Palani Sukumar
Esic Medical College and Hospital