Impact of Erector Spinae Plane Block on Postoperative Analgesia and Perioperative Stress Response in Sleeve Gastrectomy: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation.
This study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) >30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).
Demographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.
Postoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.
The primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- 是
入选标准
- •Age between 18 and 65 years
- •Body mass index (BMI) > 30 kg/m²
- •ASA physical status II-III
- •Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
- •Ability to provide written and verbal informed consent
排除标准
- •Age < 18 years or > 65 years
- •ASA physical status I, IV, or V
- •Body mass index (BMI) < 30 kg/m²
- •Contraindications to erector spinae plane block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)
- •Renal or hepatic insufficiency
- •Refusal to participate or inability to provide informed consent
研究组 & 干预措施
Group ESPB
干预措施: Erector Spinae Plane Block (Procedure)
Group Control
干预措施: Control (Procedure)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: 24 hours after surgery
The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
次要结局
- Body Weight (kilograms)(At baseline (preoperatively))
- Height (centimeters)(At baseline (preoperatively))
- Body Mass Index (BMI, kg/m²)(At baseline (preoperatively))
- Postoperative Rescue Opioid Consumption (Intravenous Tramadol, mg)(During the first 24 hours postoperatively)
- Perioperative Heart Rate (beats per minute)(Intraoperatively and during the first 24 hours postoperatively)
- Mean Arterial Pressure (mmHg)(Intraoperatively and during the first 24 hours postoperatively)
- Patient Satisfaction Assessed by a 5-Point Likert Scale at 24 Hours(24 hours postoperatively)
- Serum Cortisol Level (mg/dL)(From preoperative baseline to 24 hours postoperatively)
- Serum C-Reactive Protein (CRP) Level (mg/L)(From preoperative baseline to 24 hours postoperatively)
- Blood Glucose Level (mg/dL)(From preoperative baseline to 24 hours postoperatively)
- White Blood Cell Count (×10³/mm³)(From preoperative baseline to 24 hours postoperatively)
- Lymphocyte Percentage (%)(From preoperative baseline to 24 hours postoperatively)
- Absolute Lymphocyte Count (×10³/mm³)(From preoperative baseline to 24 hours postoperatively)
- Neutrophil Percentage (%)(From preoperative baseline to 24 hours postoperatively)
- Absolute Neutrophil Count (×10³/mm³)(From preoperative baseline to 24 hours postoperatively)
研究者
Kutay Baris FILAZI
Medical Doctor
Harran University