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临床试验/NCT06928324
NCT06928324已完成不适用

Providing Postoperative Analgesia With an Erector Spinae Plane Block in Robotic-assisted Partial Nephrectomy

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Reducing patient-controlled analgesic consumption

研究概览

简要总结

Partial nephrectomy is used as a standard method for the treatment of T1 kidney tumors, while radical nephrectomy is preferred for T2 tumors and localized masses that cannot be treated with partial nephrectomy. These surgical procedures can be performed using open surgery, laparoscopic, or robotic approaches. Open surgical methods, especially during partial or radical nephrectomy, generally require wide incisions extending below the costal arch. These incisions involve cutting through intercostal muscle structures, fascial layers, and subcutaneous tissues, which can lead to significant postoperative discomfort for the patient. This situation can directly affect the patient's comfort and recovery time. This study aims to investigate the effect of the erector spinae plane block, a method we routinely use for analgesic purposes in many procedures in anesthesia practice, on postoperative pain levels, analgesic consumption, patient satisfaction, and length of stay after robotic-assisted partial nephrectomy surgery.

Method: Patients ranging in age between 18 and 70 were randomly assigned to either Group 1 (ESPB 30 ml bupivacaine 0.25%) or Group 2 (Control)

详细描述

Ultrasound-guided regional anesthesia techniques stand out as an effective analgesia method in patients undergoing robotic-assisted partial nephrectomy (RAPN). In recent years, one of the newly defined plane blocks under ultrasound guidance, the Erector Spina Plane (ESP) Block, has become a notable alternative in postoperative pain management (4-6). The ESP block is applied at the level of the spinous process of the T8 vertebra, providing a wide sensory block in the dermatomes from T5 to T12. This technique is performed intraoperatively when the patients are in the lateral decubitus position under general anesthesia, using an ultrasound-guided linear probe. In this study, the effects of the ESP block applied to provide intraoperative and postoperative analgesia in patients undergoing robotic-assisted partial nephrectomy on postoperative pain control will be evaluated. The effectiveness of the ESP block will be comprehensively analyzed in terms of parameters such as reducing pain levels, decreasing analgesic use, increasing patient comfort, and accelerating the postoperative recovery process. Within the scope of this prospective study, general anesthesia induction will be performed using propofol and rocuronium by standard protocols, and anesthesia maintenance will be achieved with a 4-6% combination of desflurane-O₂, remifentanil, and rocuronium intravenous infusion. All procedures will be conducted within an observational clinical research protocol framework, and patients will not be subjected to any methods other than routine practices. Before the study begins, patients will be thoroughly informed, and their written consent will be obtained. The study is planned to start in April 2025.

The patient groups that will not be included in the study are as follows:

  • Patients classified as ASA III or IV,
  • Patients with cardiopulmonary difficulties,
  • Patients who have previously been diagnosed with diabetes,
  • Conditions requiring emergency surgery,
  • Patients who refuse to participate in the study,
  • Individuals with contraindications for general anesthesia,
  • Patients with less than 50 kg or more than 110 kg. Patients will be placed in the lateral decubitus position during the surgical procedure, and the surgical site will be prepared under sterile conditions. The Erector Spina Plan (ESP) block will be performed under ultrasound guidance as usual, using a Stimuplex block needle (30-degree angled, 21Gx4", 0.80x100) for this purpose. The block procedure will be performed at the level of the transverse process of the T8 vertebra. Throughout the surgical procedure, vital parameters (systolic, diastolic, and mean arterial pressure, heart rate, and SpO₂) will be regularly recorded at five-minute intervals. The amount of remifentanil used according to analgesic requirements will be systematically recorded during the intraoperative period. The patients' pain levels and analgesic needs will be assessed in the postoperative period at 1, 12, and 24 hours. In addition, the amount of morphine consumed and the need for additional analgesics based on postoperative analgesia requirements will be recorded in detail in both groups. Postoperative pain management will be provided using a patient-controlled analgesia (PCA) device by routine protocols. The PCA device offers effective and reliable pain control by allowing patients to meet their analgesic needs on an individual level. Patients will undergo robotic-assisted partial nephrectomy, and by the surgical procedure, postoperative pain management will be monitored for 24 hours, with potential complications being meticulously recorded. Postoperative pain levels will be assessed in patients both at rest and during coughing using a 0-10 Visual Analog Scale (VAS). When the pain score exceeds 3/10, 1000 mg of intravenous paracetamol will be administered as a rescue analgesic. The time of the patients' first mobilization will be recorded, and the satisfaction level of both the surgeon and the patient during the postoperative period will be rated as 1 (Excellent), 2 (Good), and 3 (Poor). Additionally, the presence of side effects such as nausea and vomiting will also be carefully recorded. Before the study, a power analysis was conducted within the framework of the central hypothesis, based on the postoperative pain rates in both groups, using the G Power (3.1.9.7 Franz Faul, Universität Kiel, Germany) program. According to data obtained from retrospective studies (6), the average morphine consumption in the group where the ESP block was applied was determined to be 16 mg. Based on the assumption that a 30% difference is clinically significant according to the unpaired t-test, a minimum of 38 patients is required for each group. However, 46 patients will be included to increase the evidence for the study.

With this calculation, the power of the study has been determined to be 0.95 and the significance level (α) to be 0.05. The normality of the data will be evaluated using the Shapiro-Wilk test, and homogeneity will be assessed using the Levene test. For data showing a normal distribution, an independent t-test will be used; for data that do not follow a normal distribution or are not homogeneous, the Mann-Whitney U test will be used; and for categorical variables, the Chi-square test will be used. The statistical significance level will be accepted as p<0.05, and all analyses will be conducted using the Windows-compatible JAMOVI (version 2.6.19) software.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •American Society of Anesthesiologists (ASA) Class I or II
  • •Having regular preoperative visits
  • •Pregnant aged 18-70

排除标准

  • •Patients classified as ASA III or IV,
  • •Patients with cardiopulmonary difficulties,
  • •Patients who have previously been diagnosed with diabetes,
  • •Conditions requiring emergency surgery,
  • •Patients who refuse to participate in the study,
  • •Individuals with contraindications for general anesthesia,
  • •Patients who weighed less than 50 kg or more than 110 kg.

研究组 & 干预措施

ESPB group

Active Comparator

Receiving ESPB 30 ml bupivacaine 0.25%

干预措施: Erector Spinae Plane block (Procedure)

control group

Active Comparator

Not receiving ESBP

干预措施: Control (Procedure)

结局指标

主要结局

Reducing patient-controlled analgesic consumption

时间窗: From the patient's anesthesia induction in the operating room to the postoperative 24. hours

The amount of analgesic consumption first 24 hours in the postoperative period

次要结局

  • the satisfaction of the surgeon and the patient during the postoperative period(From the patient's anesthesia ending to the postoperative 24. hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kudret Dogru

Prof. Dr.

TC Erciyes University

研究点 (1)

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