Estimation of Intraoperative Anaesthetic Drug Requirement in General Anaesthesia With or Without Erector Spinae Plane Block in Lumbar Spondylolisthesis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraoperative Opioid Requirements (Fentanyl in micrograms)
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane (ESP) block as an adjunct to general anesthesia for managing postoperative pain in patients undergoing lumbar spondylolisthesis surgery. The study will compare two groups: one receiving general anesthesia with ESP block (intervention group) and the other receiving general anesthesia alone (control group). The primary objective is to assess postoperative pain relief, opioid consumption, and hemodynamic stability. Secondary outcomes include adverse events and recovery quality. This trial will provide valuable insights into the efficacy of ESP block in improving recovery outcomes and reducing opioid use in spine surgery patients.
详细描述
This study is designed as a quasi-experimental trial to investigate the efficacy of the ultrasound-guided erector spinae plane (ESP) block in combination with general anesthesia for postoperative pain management in patients undergoing lumbar spondylolisthesis surgery. This clinical trial will recruit 50 adult patients scheduled for elective lumbar spine surgery, who are assigned to either the intervention or control group.
Intervention Group (Group B): Patients will receive ultrasound-guided ESP block as an adjunct to standard general anesthesia.
Control Group (Group A): Patients will receive general anesthesia without the erector spinae plane (ESP) block.
The trial will evaluate pain control (measured by Visual Analogue Scale [VAS] scores), opioid consumption, and hemodynamic parameters (such as heart rate, blood pressure, and oxygen saturation). Additionally, postoperative recovery quality, the incidence of adverse events, and any potential complications associated with the erector spinae plane (ESP) block will be monitored and compared between groups.
This trial also aims to assess whether the use of the erector spinae plane (ESP) block can reduce opioid consumption, improve hemodynamic stability, and enhance recovery quality in the postoperative period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing lumbar spondylolisthesis surgery.
- •Elective procedures.
- •Age between 18 to 64 years.
- •American Society of Anaesthesiologists (ASA) physical status 1 and 2.
排除标准
- •Patient refusal.
- •Body Mass Index (BMI) >35 kg/m2
- •Coagulopathy or bleeding disorders.
- •Allergy to any of the study drugs.
- •Substance abuse or dependence or previous history of opioid addiction.
- •Patients with central nervous system disease, severe cardiovascular system disease, hepatic disease or renal disease.
- •Local infection or inflammation at the site of block placement.
研究组 & 干预措施
Control Group: General Anesthesia Without Erector Spinae Plane Block
Control Group: General Anesthesia Without Erector Spinae Plane Block In this group, patients will receive standard general anesthesia without the addition of an ultrasound-guided erector spinae plane (ESP) block. This arm will serve as the comparison group to assess the impact of the ESP block on postoperative pain and recovery outcomes.
干预措施: Control Group: General Anesthesia Without Erector Spinae Plane Block (Procedure)
Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block
Intervention Group: General Anaesthesia With Ultrasound-Guided Erector Spinae Plane (ESP) Block In this group, patients will receive general anaesthesia in combination with an ultrasound-guided erector spinae plane block. The aim is to evaluate whether adding the ESP block improves postoperative pain control, reduces opioid consumption, and enhances hemodynamic stability during and after lumbar spondylolisthesis surgery.
干预措施: Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block (Procedure)
结局指标
主要结局
Intraoperative Opioid Requirements (Fentanyl in micrograms)
时间窗: Throughout the duration of surgery.
The total amount of opioid (fentanyl in microgram) administered during surgery. The goal is to evaluate the opioid consumption required to maintain adequate analgesia during the procedure.
Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements
时间窗: Throughout the duration of surgery
Description: The total consumption of inhalational anesthetic agents (Isoflurane in ml/hour) during the surgical procedure. This measure will help assess the inhalational anaesthetic requirement between groups.
Intraoperative Muscle Relaxant (vecuronium in mg) Requirements
时间窗: Throughout the duration of surgery
The total dose of muscle relaxant (vecuronium, in mg) is administered to maintain muscle relaxation during surgery. This will be compared between the two groups.
次要结局
- Intraoperative heart rate (HR)(Recorded at 15-minute intervals during the surgery)
- Intraoperative Systolic Blood Pressure (mmHg)(Recorded at 15-minute intervals during the surgery)
- Intraoperative diastolic blood pressure (mmHg)(Recorded at 15-minute intervals during the surgery)
- Intraoperative Mean Arterial Pressure (mmHg)(Recorded at 15-minute intervals during the surgery)
研究者
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University