Efficacy of Ultrasound-Guided Erector Spinae Plane Block in Postoperative Pain Management in Nephrectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) for pain
研究概览
简要总结
This clinical trial aims to evaluate the effectiveness of the ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain for patients undergoing open nephrectomy (kidney removal surgery). The study will compare this new technique to traditional pain management methods, such as opioid medications, to assess whether the ESP block reduces pain and the need for opioids after surgery.
Patients will be randomly assigned to one of two groups:
Group C will receive conventional pain relief methods, including opioids. Group E will receive the ultrasound-guided ESP block in addition to general anesthesia.
The main goals are to determine:
How much pain relief each method provides, measured using a visual analog scale (VAS).
The total amount of opioids required during the first 24 hours post-surgery.
Additional measurements will include monitoring vital signs like heart rate, blood pressure, and oxygen levels.
This study will help find safer and more effective ways to manage pain after nephrectomy, reducing the reliance on opioids and improving patient recovery
详细描述
This randomized controlled trial aims to assess the efficacy of ultrasound-guided erector spinae plane (ESP) block in managing postoperative pain in patients undergoing open nephrectomy. Nephrectomy, a common procedure for kidney removal, often results in severe postoperative pain, which can contribute to complications such as postoperative pulmonary complications (PPC) and delayed recovery. Traditional analgesic techniques, including systemic opioids and epidural analgesia, have various side effects such as nausea, vomiting, constipation, and respiratory depression. Additionally, opioids may lead to tolerance, especially in cancer patients. Erector spinae plane block (ESP) is a newer regional technique that has gained attention due to its potential to provide effective analgesia with minimal side effects.
This study will evaluate whether the ESP block can provide better pain control and reduce opioid consumption compared to conventional pain management techniques. The ESP block targets the erector spinae muscle and provides analgesia via fascial plane blocks, which is believed to be effective in controlling visceral and somatic pain, typically associated with nephrectomy.
The trial will involve 66 adult patients scheduled for open nephrectomy under general anesthesia. Patients will be randomly assigned to one of two groups:
Control Group (Group C): Patients will receive conventional analgesia, including opioids and standard local anesthetic techniques.
Intervention Group (Group E): Patients will receive general anesthesia combined with the ultrasound-guided ESP block, administered immediately before anesthesia induction.
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)
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
- •Adult patients aged 18 to 64 years
- •Scheduled for open nephrectomy (radical or partial) under general anesthesia
- •ASA physical status I-II (American Society of Anesthesiologists classification)
排除标准
- •Allergy to local anesthetics.
- •Local infection or inflammation at the site of the Block placement.
- •Presence of anatomical deformities in the spine
- •Coagulopathy or any bleeding disorder.
- •Pregnancy or breastfeeding women.
- •History of severe chronic pain syndrome
研究组 & 干预措施
Control Group: Conventional Pain Management
This group will receive general anesthesia along with conventional pain management techniques, including opioid analgesics and other standard interventions typically used in postoperative nephrectomy care
Intervention Group: Ultrasound-Guided Erector Spinae Plane Block
Patients in this group will receive general anesthesia in combination with the ultrasound-guided erector spinae plane (ESP) block, administered before the induction of anesthesia. The block targets the erector spinae muscle fascial plane, aiming to reduce postoperative pain and opioid consumption.
干预措施: Ultrasound-Guided Erector Spinae Plane (ESP) Block (Procedure)
结局指标
主要结局
Visual Analogue Scale (VAS) for pain
时间窗: VAS score will be The VAS score will be recorded within the first 24 hours after surgery upon the patient's arrival in recovery, at 1, 3, 6,12 and 24 hours.
VAS score measures the intensity of pain, with 0 indicating no pain and 10 indicating the worst possible pain. A lower VAS score means less pain and better pain management. A higher VAS score means more pain and poorer pain control.
次要结局
- Total Opioid Consumption(Total opioid consumption will be calculated and recorded in mg within the first 24 hours postoperatively.)
- Peak Expiratory Flow Rate (PEFR)(PEFR values will be assessed preoperatively and at arrival to 1, 3, 6, and 24 hours postoperatively.)
- Heart Rate (HR) Monitoring(Heart rate (HR) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.)
- Systolic Blood Pressure (SBP) Monitoring in mmHg(Systolic blood pressure (SBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.)
- Diastolic Blood Pressure (DBP) Monitoring in mmHg(Diastolic blood pressure (DBP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.)
- Mean Arterial Pressure (MAP) Monitoring in mmHg(Mean arterial pressure (MAP) will be measured preoperatively and at 0, 1, 3, 6, 12, and 24 hours postoperatively.)
研究者
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University