Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Anterior Quadratus Lumborum Block in Elderly Patients Undergoing Total Hip Replacement Surgeries: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- The Total Amount of Morphine Consumption
研究概览
简要总结
The investigators hypothesis that PENG block will produce effective opioid sparing analgesia with enhanced motor recovery more than AQLB in elderly patients undergoing total hip replacement surgeries
详细描述
Aim of the work:
The aim of this study is to compare analgesic efficacy and motor recovery of the ultrasound guided anterior quadratus lumborum block and the pericapsular nerve group block
Statistical Analysis
Data will be coded and entered using the statistical package SPSS version 22. Categorical data will be expressed frequency and proportion and will be compared by Chi2. Numerical data will be summarized using mean and standard deviation. Comparisons between groups for normally distributed data will be done using analysis of variance (ANOVA), while for non-normally distributed numeric variable will be done by Krauskal Wallis test. P value less than or equal to 0.05 will be considered statistically significant. All test will be two tailed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Type of surgery; unilateral elective total hip replacement.
- •Physical status ASA I- III
- •Age ≥ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m
- •Traumatic fracture hip through anterolateral approach.
排除标准
- •Patient refusal.
- •Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics & opioids).
- •History of psychological disorders and/or chronic pain.
- •Pre- existing peripheral neuropathies
- •Coagulopathy.
- •Infection of the skin at the site of needle puncture area.
- •Active cardiac condition (unstable coronary syndromes, significant arrhythmias, severe valvular disease).
- •Acute respiratory disease (active chest infection, respiratory failure).
- •Advanced liver disease (increased liver enzymes >3 folds) or severe kidney disease (creatinine >2).
- •long operative time more than 3 hours.
研究组 & 干预措施
Anterior quadratus lumborum block technique (AQLB)
AQLB performed in the lateral position. A low-frequency convex probe for the abdomen (2-5) MHz convex probe, (Siemens ACUSON X300 Ultrasound System) was placed horizontally above the iliac crest. On ultrasound, The psoas major was located on the ventral side of the transverse process, the erector spinae was located on the dorsal side of the transverse process, and the quadratus lumborum was located on the lateral side of the transverse process.
A 38-mm 22-gauge regional block needle was advanced in-plane from posterior to anterior directing the needle tip in the fascial plane between the psoas major and the quadratus lumborum that was confirmed by injecting 1 ml saline and watchingt the fluil fting the muscle while not distending any of the two muscles (hydro-localization). Then 30mL of local anaesthetic (29ml of 0.25% bupivacaine + 1 ml of dexamethasone (4mgs) was injected with observation of local anaesthesia spread in the fascial plane.
干预措施: Anterior quadratus lumborum block technique (AQLB) (Procedure)
Pericapsular Nerve Group (PENG) block
With the patients in supine position, A low-frequency convex probe (2-5 MHz) in was placed in a transverse plane over the anterior inferior iliac spine and then it was rotated 45 degrees in counter-clockwise direction to be aligned with the pubic ramus. In this view, the ilio-pubic eminence, iliopsoas muscle tendon, femoral nerve and vessels was observed. With in-plane approach, a 38-mm 22-gauge (22-G, 50-mm) regional block needle inserted in-plane, from lateral to medial to place the needle tip underneath the iliopsoas tendon, exactly between the ilipsoas fascia anteriorly and the pubic ramus posteriorly. Following negative resistance and aspiration tests, correct location of the needle tip was confirmed by injecting 1 ml saline. Then, 30mL of local anaesthetic (29ml of 0.25% bupivacaine+ 1ml of dexamethasone (4mgs) was injected while observing for adequate fluid spread.
干预措施: Pericapsular Nerve Group (PENG) block (Procedure)
Control Group
Pataints received opioid analgesia with GA
干预措施: Control Group (Drug)
结局指标
主要结局
The Total Amount of Morphine Consumption
时间窗: Immediatly post operative for 24 hours
Total dose of IV morphine (mg) administered as rescue analgesia during the first 24 postoperative hours. Morphine 0.05 mg/kg IV boluses were given when NRS ≥4, up to a maximum of 0.3 mg/kg/24 h. Reported as median (IQR).
次要结局
- Numeric Pain Rating Scale at Rest Over First 24 Hours(30 minutes, 2, 4, 6, 8, 12, 18, and 24 hours after surgery)
- Numeric Pain Rating Scale During Passive 90° Hip Flexion Over First 24 Hours(at 30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively)
- Time to First Rescue Morphine Analgesia(Immediatly post operative for 24 hours)
- Manual Muscle Test (MMT) Score for Quadriceps/Iliopsoas Over First 24 Hours(30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively)
- Active Hip Flexion Range of Motion (0°-90°) Over First 24 Hours(30 minutes, 2, 4, 6, 8, 12, 18 and 24 hours postoperatively)
- Total Intraoperative Fentanyl Dose(During surgery)
- Time to First Walk(From end of surgery until first walk (within postoperative 24 h))
- Length of Hospital Stay(From date of surgery until discharge)
研究者
Mohamed Youssef
Assistant Professor
Cairo University