Ultrasound Guided Techniques for Postoperative Analgesia in Patients Undergoing Open Upper Abdominal Surgeries: External Oblique Intercostal Plane Block vs. Quadratus Lumborum Block; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to first requested rescue analgesia (minutes)
研究概览
简要总结
Open upper abdominal surgeries with subcostal incisions are a cause of severe pain and can lead to pulmonary and cardiac complications, detrimental physiological effects, and may also have psychological, economic, and social adverse effects if inadequately treated. Effective pain control can avoid these complications and contribute to several clinically valuable outcomes, including earlier patient mobilization and quicker recovery, which can result in a shortened hospital stay and reduced costs.
Opioids are the gold standard in postoperative pain control. however, it increases the incidence of opioid related adverse events such as respiratory depression, dizziness, nausea, vomiting and constipation. Regional analgesia plays an important role in perioperative multimodal analgesic regimens for major abdominal surgeries. The ultrasound-guided technique provides several options for relieving postoperative pain.
The aim of this study is to compare the efficacy and safety of ultrasound guided external oblique intercostal plane block versus quadratus lumborum in patients undergoing open upper abdominal surgeries.
详细描述
Poorly controlled postoperative pain causes physiological stress, increased morbidity, delayed mobilization, prolonged hospitalization, and higher healthcare costs.
Regional anelgesia techniques have shown a promise in improving postoperative outcomes by reducing opioid consumption and related adverse effects.
This study aims to evaluate two regional blocks - EOIPB and QLB- both will be performed under ultrasound guidance.
The goal is to determine which technique offers superior analgesic efficacy, safety and overall contribution to the quality of recovery.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from both sexes.
- •18 to 60 years old.
- •ASA physical status I- III scheduled for elective open upper abdominal surgeries, as (open nephrectomy, open cholecystectomy, liver resection, ....).
- •Patients with BMI (18.5-35) kg/ m2.
排除标准
- •Patients uncooperative or refuse to sign the consent of regional block.
- •Patients with known coagulation defects. International normalized ratio (INR)> 1.5), and thrombocytopenia if platelet count < 100.000).
- •Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
- •Patients with hepatic impairment, as Child-Pugh class B or C, AST/ALT > 3 times the upper limit of normal, or total bilirubin > 2 mg/dL.
- •Patients with renal impairment, chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73 m²), or on regular dialysis.
- •Patients with pre-existing myopathy, defined as a clinically diagnosed muscular disorder characterized by muscle weakness, elevated creatine kinase levels, or a history of inherited or acquired muscle disease (e.g., polymyositis, muscular dystrophy).
- •Patients with pre-existing neuropathy, if clinically diagnosed as peripheral or central nerve dysfunction, including chronic sensorimotor deficits or conditions such as diabetic neuropathy, radiculopathy, or multiple sclerosis.
- •Patients with chronic pain syndromes, defined as pain persisting for more than 3 months, including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
- •Patients with sepsis at the site of injection.
- •Patients with history of long-acting opioids or steroids preoperatively
研究组 & 干预措施
Group External Oblique Intercostal Plain Block (EOIPB)
Patients will receive general anesthesia initially then unilateral EOIPB with total volume 30 ml of bupivacaine 0.25% will be performed.
干预措施: External Oblique Intercostal Plain Block (Procedure)
Group External Oblique Intercostal Plain Block (EOIPB)
Patients will receive general anesthesia initially then unilateral EOIPB with total volume 30 ml of bupivacaine 0.25% will be performed.
干预措施: Bupivacaine %0.25 (isobaric) (Drug)
Group Quadratus Lumborum Block (QLB)
Patients will receive general anesthesia initially then unilateral QLB with total volume 30 ml of bupivacaine 0.25% will be performed.
干预措施: Quadratus Lumborum Block (Procedure)
Group Quadratus Lumborum Block (QLB)
Patients will receive general anesthesia initially then unilateral QLB with total volume 30 ml of bupivacaine 0.25% will be performed.
干预措施: Bupivacaine %0.25 (isobaric) (Drug)
结局指标
主要结局
Time to first requested rescue analgesia (minutes)
时间窗: 24 hours postoperatively
次要结局
未报告次要终点
研究者
Ahmed Shaaban Glall Ismail
Dr
Cairo University