Perioperative Efficacy of Erector Spinae Plane Block in Patients Undergoing Percutaneous Nephrolithotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total Postoperative Tramadol Consumption within 24 Hours
研究概览
简要总结
Percutaneous nephrolithotomy (PCNL) is an effective standard urological procedure for the fragmentation and removal of large renal calculi. Although PCNL is performed as a minimally invasive technique, dilation of the renal capsule and parenchymal tract, as well as peritubular distension caused by the nephrostomy tube, may result in severe postoperative pain. Various analgesic strategies have been described in the literature for postoperative pain management following PCNL. These include systemic opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and several regional analgesia techniques. However, due to their adverse effect profiles, opioids and NSAIDs are not ideal options, particularly in patients with renal dysfunction. Regional techniques that have been utilized include local infiltration, intercostal nerve blocks, paravertebral blocks, and epidural analgesia.
The kidney is primarily innervated between the T10 and L1 segments, whereas the ureter receives innervation from T10 to L2. Based on this anatomical knowledge, unilateral regional blockade between T10 and L2 can provide adequate analgesia for PCNL procedures. Thoracic paravertebral block was previously a commonly preferred technique; however, it may be associated with complications such as intravascular injection, unintended epidural or intrathecal spread, and pneumothorax during its performance. In recent years, the number of reports describing the use of the erector spinae plane block (ESPB) as part of multimodal anesthesia for postoperative analgesia has increased. In ESPB, local anesthetic is injected into the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, and has been reported to spread to multiple paravertebral spaces. ESPB is considered a peri-paravertebral block that can affect both visceral and somatic pain pathways.
The aim of this study is to evaluate the effect of ultrasound-guided erector spinae plane block on intraoperative and postoperative opioid consumption, postoperative pain scores, and quality of recovery in patients undergoing percutaneous nephrolithotomy.
详细描述
This clinical trial is designed to evaluate the perioperative efficacy of ultrasound-guided ESPB in adult patients undergoing percutaneous nephrolithotomy under general anesthesia.
After enrollment, patients will be randomly allocated into two groups using a closed-envelope method: an ESPB group and a control group. All patients will receive a standardized general anesthesia protocol. Anesthesia induction will be performed with propofol 2 mg/kg Propofol®, Polifarma İlaç San.ve Tic. A.Ş., Türkiye), rocuronium 0.6 mg/kg (Esmeron®, Merck Sharp Dohme İlaçları LTD Şti, Türkiye)as neuromuscular blocker, and remifentanil 1 µg/kg (ultan, centurion pharma, İstanbul, Türkiye) as opioid. Additional rocuronium 0.1 mg/kg will be administered intraoperatively as needed to maintain muscle relaxation. Anesthesia will be maintained with 2% sevoflurane (Sevorane®, Abbott, Chicago, ABD) in 50% oxygen and a continuous infusion of remifentanil at 0.1-1 µg/kg/min, titrated according to hemodynamic responses. Invasive arterial blood pressure monitoring will be used for close hemodynamic follow-up in all patients.
In the ESPB group, following induction of general anesthesia and prior to surgical incision, an ultrasound-guided ESPB will be performed at the T10 transverse process level on the side of the surgical kidney. Under aseptic conditions, using an in-plane technique, a total of 20 mL of 0.25% bupivacaine (Marcaine® %0,5, AstraZeneca, İstanbul, Türkiye)will be injected between the erector spinae muscle and the transverse process. In the control group, no additional regional block or sham procedure will be performed; patients will undergo surgery under general anesthesia with the same standardized systemic analgesia protocol as the ESPB group.
Intraoperative hemodynamic parameters, including mean arterial pressure and heart rate, will be recorded at predefined time points, and total intraoperative remifentanil consumption will be documented. At the end of surgery, all patients will receive 15 mg/kg paracetamol and 0.5 mg/kg meperidine intravenously as part of the standard postoperative analgesic regimen. During postoperative ward follow-up, all patients will receive 15 mg/kg paracetamol four times daily. Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at 0, 2, 4, 6, 12, and 24 hours after surgery. For patients with NRS ≥ 3, intravenous tramadol 1 mg/kg will be administered as rescue analgesia, and total postoperative tramadol consumption within the first 24 hours will be recorded.
Postoperative nausea and vomiting will be evaluated at 0, 2, 4, 6, 12, and 24 hours postoperatively, and the presence or absence of symptoms will be documented. Quality of recovery will be assessed at 24 hours after surgery using the Turkish validated version of the 15-item Quality of Recovery questionnaire (QoR-15T). The total QoR-15T score ranges from 0 to 150, with higher scores indicating better quality of recovery. Postoperative pain assessments and QoR-15T evaluations will be performed by nurses who are blinded to group allocation, ensuring assessor blinding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researchers performing the block procedures were not involved in the postoperative assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Scheduled for elective percutaneous nephrolithotomy under general anesthesia.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Age < 18 years.
- •ASA physical status III-IV.
- •Refusal to participate in the study.
- •Known allergy or contraindication to local anesthetics (bupivacaine), opioids, or study medications.
- •Coagulopathy or anticoagulant therapy contraindicating regional block.
- •Infection at the injection site.
- •Severe psychiatric or cognitive disorder precluding reliable pain assessment or questionnaire completion.
研究组 & 干预措施
Block group
Standard pain management + Erector spinae plane block
干预措施: Erector Spinae Plane Block (Procedure)
Control group
Patients will receive standard general anesthesia and perioperative systemic analgesia, but erector spinae plane block will not be performed.
结局指标
主要结局
Total Postoperative Tramadol Consumption within 24 Hours
时间窗: 0-24 hours postoperatively
Total dose of intravenous tramadol (mg) administered as rescue analgesia during the first 24 hours after surgery.
次要结局
- QoR-15T (Turkish) quality of recovery scale(Postoperative 24th hours, based on a single assessment)
- Intraoperative Remifentanil Consumption(İntraoperative period)
- Postoperative Pain Scores (NRS)(Postoperative 0th, 2nd, 4th, 6th, 12th and 24th hours)
研究者
Fadime Tosun
Assistant Professor
Adiyaman University