A Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Combined Ultrasound Guided Pericapsular Nerve Group (PENG) and Lateral Femoral Nerve Block Following Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
研究概览
简要总结
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive Pericapsular nerve group block and lateral femoral cutaneous nerve blocks.
Group B: Patients will receive Erector spinae plane block.
After IV access insertion and oxygen nasal cannula application, monitoring will be applied for all patients, sedation in the form of midazolam 0.02mg/kg with or without fentanyl 0.5-1 mcg/kg will be administered to any of the patients who felt discomfort or could not tolerate the procedure.
For (Group A) PENG block will be done before spinal anesthesia.
LFCN block will be performed.
For (Group B), ESP block will be done before spinal anesthesia.
Spinal anesthesia will be chosen as the main anesthetic technique.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities and depending on the patients" needs.
详细描述
The patients will be randomized into 2 equal groups by a computer-generated random numbers table, named group A, B.
Group A: patients will receive PENG and LFCN blocks.
Group B: Patients will receive ESP block, which will be the control group.
After obtaining approval from Ain Shams hospital academic and ethical committee, written, informed and valid consent will be taken from all participants after proper explanation of the study procedure and the expected outcome in a clear language for patients of either sex, aging from 18 to 65 years old, ASA physical status (I, II) scheduled for total hip arthroplasty surgeries.
Patients with the following criteria will be excluded from the study: Patient refusal, ASA physical status III or more, known allergy to any of the study drugs, infection at the site of injection, history of cardiovascular, renal, hepatic or neuromuscular diseases, history of any psychiatric disorder, presence of any coagulopathy, chronic opioid, gabapentin or pregabalin use, BMI more than 35 kg/m2. Patients will be randomly assigned to either both PENG and LFCN blocks and ESP block with ultrasound guidance before spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients American Society of anesthesiologists' physical status (ASA) I to III.
- •Aged 18 to 65 years.
- •Both sexes.
- •Patients scheduled for total hip arthroplasty.
排除标准
- •Patient refusal
- •ASA physical status III or more.
- •Patients with known allergy to any of the study drugs.
- •Infection at the site of injection.
- •Patients with history of cardiovascular disease.
- •Patients with renal disease.
- •Patients with hepatic disease.
- •Patients with neuromuscular disease.
- •Presence of any coagulopathy.
- •Chronic opioid, gabapentin or pregabalin use.
- •Patients with history of any psychiatric disorder.
- •BMI more than 35 kg/m2.
结局指标
主要结局
individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
时间窗: 48 hours
The primary outcomes include : individual visual analog pain scores at 0, 6, 12, 24 and 48 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
时间窗: 48 hours
presence of moderate-to-severe pain, defined as pain score 4 or greater during the first 48 h postoperative.
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
时间窗: 48 hours
analgesic consumption in post-anesthesia care unit, and during the first 48 h post-surgery (converted to IV pethidine equivalents).
次要结局
未报告次要终点
研究者
riham fathy galal
Lecturer
Ain Shams University