Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (VAS)
研究概览
简要总结
This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.
详细描述
Erector spinae plane (ESP) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. While the ESP block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance.
This prospective, randomized, single-blind study investigates the impact of administering bilateral ESP block at the T7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. The study includes adult patients (aged 18-65, ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia.
Primary outcomes include postoperative pain scores (VAS and NRS). Secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (Likert scale), and measurement of the skin-to-block site distance across different positions. Data will be collected at defined intervals up to 24 hours postoperatively.
The findings are expected to inform clinicians on the optimal patient positioning for ESP block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The person evaluating postoperative pain scores and satisfaction will be blinded to group assignment.
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
- •Age between 18 and 65 years
- •Scheduled for elective laparoscopic cholecystectomy
- •ASA physical status I-II
- •Ability to understand and provide written informed consent
排除标准
- •Allergy to local anesthetics
- •History of chronic opioid use or substance abuse
- •Coagulopathy or current anticoagulant therapy
- •Local infection at the block site
- •Severe spinal deformities or scoliosis
- •BMI > 35 kg/m²
- •Pregnancy or breastfeeding
- •Refusal to participate in the study
研究组 & 干预措施
Lateral Position Group
Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.
干预措施: Erector Spinae Plane (ESP) Block (Procedure)
Prone Position Group
Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.
干预措施: Erector Spinae Plane (ESP) Block (Procedure)
Sitting Position Group
Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.
干预措施: Erector Spinae Plane (ESP) Block (Procedure)
结局指标
主要结局
Postoperative Pain Score (VAS)
时间窗: 0, 2, 4, 6, 12, and 24 hours postoperatively
Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points following laparoscopic cholecystectomy. The goal is to compare postoperative pain scores between patient groups receiving ESP block in lateral, prone, or sitting positions.
次要结局
- Total Postoperative Analgesic Consumption(First 24 hours after surgery)
- Time to First Analgesic Request(Within 24 hours postoperatively)
- Patient Satisfaction Score(24 hours postoperatively)
- Skin-to-Target Distance(During preoperative ESP block procedure)
研究者
Veli Fahri Pehlivan
Assistant Professor
Harran University