Comparative Study of Ultrasound-guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Open Nephrectomy for Renal Malignancy: A Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Total morphine consumption within 24 hours postoperative
研究概览
简要总结
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
详细描述
The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra. Hence, LA is distributed in the cranio-caudal fascial plane. Additionally, it diffuses anteriorly to the paravertebral and epidural spaces, and laterally to the intercostal space at several levels.
Cadaveric studies was done on ESPB using MRI to evaluate the spread of local anesthetic mixed with gadolinium dye. Showed the spread of injected volume of 30 ml at level of T10 spread between the level of T5 and T12 . Other cadaveric study showed the spread of the dye to thoracic paravertebral space which may explain the visceral analgesic effect of the block.
There are different case studies about the use of erector spinae block (ESPB ) in nephrectomy, but there are no enough randomized controlled studies about it until now so it will be one of the earliest studies that investigate the effect of ESPB to relief acute postoperative pain in patients undergoing open nephrectomy.
Although ESPB and thoracic epidural analgesia blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing open nephrectomy under general anesthesia thus in this randomized comparative study we are aiming to fill this gap in the literature.
The aim of this study is to compare the analgesic effect of ultrasound-guided continuous erector spinae plane block versus thoracic epidural analgesia in open nephrectomy for renal cancer patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists class II.
- •Patients undergoing open nephrectomy for malignant renal tumors.
- •Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
排除标准
- •Patient refusal.
- •Local infection at the puncture site.
- •Coagulopathies with platelet count below 50,000 or an international normalized ratio >1.
- •Renal and hepatic insufficiency.
- •Unstable cardiovascular disease.
- •History of psychiatric and cognitive disorders.
- •Patients allergic to medication used.
- •Abnormal anatomy of the thoracic region.
研究组 & 干预措施
Thoracic epidural analgesia group
After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
干预措施: Thoracic epidural analgesia (Procedure)
Ultrasound guided continuous erector spinae plane block group
After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 20 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 10 ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
干预措施: Ultrasound guided continuous erector spinae plane block (Procedure)
结局指标
主要结局
Total morphine consumption within 24 hours postoperative
时间窗: First 24 hours postoperatively.
Rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score \>3. The total amount of morphine given in 24 hours will be recorded for every patient.
次要结局
- Changes in Intraoperative heart rate(Intraoperatively)
- Changes in Intraoperative mean arterial pressure(Intraoperatively)
- Changes in postoperative heart rate(First 24 hours postoperatively.)
- Total intra-operative fentanyl consumption.(Intra-operative)
- The time of first rescue analgesia.(First 24 hours postoperatively.)
- Pain using Numerical rating scale (NRS) at rest(First 24 hours postoperatively.)
- Total dose of bupivacaine consumption.(First 24 hours postoperatively.)
- Pain using Numerical rating scale (NRS) during movement(First 24 hours postoperatively.)
- Changes in postoperative mean arterial blood pressure(First 24 hours postoperatively.)
- The incidence of various side effects .(Intra-operative and first 24 hours postoperatively.)