Preoperative and Postoperative Erector Spinae Plane Block: Effects on Frontal QRS-T Angle in Laparoscopic Surgery - A Prospective Randomized Study
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
- Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG
研究概览
简要总结
This study aims to investigate the effects of preoperative and postoperative Erector Spinae Plane (ESP) block on the frontal QRS-T angle, a marker of cardiac electrophysiological instability, in patients undergoing laparoscopic cholecystectomy. A total of 120 patients aged 18-65 with ASA I-II status will be randomized into three groups: Control (no ESP), Preoperative ESP, and Postoperative ESP. Electrocardiograms (ECGs) will be obtained preoperatively and one hour postoperatively to assess changes in QRS-T angle and other repolarization parameters. This randomized controlled trial will help clarify the potential cardiac effects of ESP block depending on its timing and may provide insight into optimizing anesthetic safety in surgical patients.
详细描述
Erector Spinae Plane (ESP) block is widely used in laparoscopic surgeries for postoperative pain control due to its simplicity and efficacy. However, its influence on the autonomic nervous system and subsequent cardiovascular effects, including changes in cardiac electrophysiological parameters, remains insufficiently understood. The frontal QRS-T angle has emerged as a novel and reliable ECG-derived marker associated with increased cardiac risk and ventricular repolarization heterogeneity.
This prospective, randomized, controlled, single-center trial aims to evaluate the impact of ESP block timing on the frontal QRS-T angle. A total of 120 adult patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned into three groups:
Control group (no ESP block),
Preoperative ESP block group,
Postoperative ESP block group.
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
- None
盲法说明
This is an open-label study due to the nature of the ESP block procedure, which prevents blinding of participants and care providers.
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 18-65 years
- •ASA physical status I-II
- •Scheduled for elective laparoscopic cholecystectomy
- •Voluntary written informed consent obtained
- •Normal preoperative 12-lead ECG (no conduction abnormalities or arrhythmias)
排除标准
- •History of cardiac disease (e.g., arrhythmia, myocardial infarction, heart failure)
- •Current use of medications affecting cardiac conduction (e.g., antiarrhythmics, beta-blockers)
- •Known allergy to local anesthetics
- •Coagulation disorders or current anticoagulant therapy
- •Pregnancy or breastfeeding
- •Local infection or anatomical deformity at the ESP block injection site
- •Patients with psychiatric or neurological disorders impairing cooperation
研究组 & 干预措施
Postoperative ESP Block Grou
Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
干预措施: Postoperative Erector Spinae Plane Block (Procedure)
Preoperative ESP Block Group
Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.
干预措施: Preoperative Erector Spinae Plane Block (Procedure)
Preoperative ESP Block Group
Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.
干预措施: Standard General Anesthesia (Procedure)
Preoperative ESP Block Group
Patients in this group will receive bilateral ultrasound-guided erector spinae plane (ESP) block at the T7 level with 20 mL of 0.25% bupivacaine on each side (total 40 mL) before the induction of general anesthesia. ECG will be recorded preoperatively and at 1 hour postoperatively. Frontal QRS-T angle, QT interval, QTc, Tp-e interval, and Tp-e/QTc ratio will be analyzed.
干预措施: Bupivacaine (Drug)
Postoperative ESP Block Grou
Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
干预措施: Standard General Anesthesia (Procedure)
Postoperative ESP Block Grou
Patients in this group will undergo standard general anesthesia. At the end of surgery, bilateral ESP block will be applied at the T7 level using 20 mL of 0.25% bupivacaine per side. ECG will be taken preoperatively and at 1 hour after surgery to evaluate changes in cardiac electrophysiologic parameters including the Frontal QRS-T angle.
干预措施: Bupivacaine (Drug)
Control Group (No ESP Block)
Patients in the control group will receive standard general anesthesia only, without any regional block. Preoperative and 1-hour postoperative ECGs will be obtained for comparison of electrophysiologic markers such as Frontal QRS-T angle, QT, QTc, Tp-e, and Tp-e/QTc.
干预措施: Standard General Anesthesia (Procedure)
结局指标
主要结局
Change in Frontal QRS-T Angle Between Preoperative and Postoperative ECG
时间窗: From 1 hour before surgery to 1 hour after surgery
The primary outcome is the change in frontal QRS-T angle measured on 12-lead ECG before surgery (baseline) and 1 hour after laparoscopic cholecystectomy. This angle is a marker of ventricular repolarization heterogeneity and potential cardiac risk.
次要结局
- Change in QT Interval (QTc) Pre- and Postoperatively(From 1 hour before surgery to 1 hour after surgery)
- Postoperative Pain Intensity Based on Visual Analog Scale (VAS)(At 2, 6, 12, and 24 hours postoperatively)
研究者
Veli Fahri Pehlivan
Assistant Professor
Harran University