Erector Spinae Plane Block for Patients Undergoing Open Renal Surgery Through Flank Incision: A Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia
研究概览
简要总结
Erector spinae plane block (ESPB) is a relatively new plane block that was first described by Forero et al. in 2016, to manage persistent neuropathic pain following malunited rib fracture and persistent post-thoracotomy neuropathic pain.It's a relatively simple, ultrasound guided block in which the local anesthetic drugs are injected in the plane between the erector spinae muscle and the vertebral transverse process.This allows the injected local anesthetics to block the ventral and dorsal rami of the spinal nerves in the paravertebral area.
The literature reveals successful case reports denoting the use of ESPB for pain control in cases of acute kidney transplant,percutaneous nephrolithomy, abdominal surgeries including laparoscopic and open nephrectomy, and nephrectomy in the pediatric population.
The aim of this prospective randomized controlled study is to investigate the efficacy of ESPB for pain control in adult patients undergoing open renal surgery through a flank incision with respect to pain scores, postoperative analgesia consumption and patient satisfaction.
详细描述
This is a prospective randomized controlled study which will be conducted in the Anesthesiology Department at Theodor Bilharz Research Institute after approval by the institutional review board and obtaining patient informed consent. 46 patients will be enrolled in the study and will be randomized to be equally divided into two groups: ESPB group(E group) and control group (C group).
Anesthetic technique:
A preoperative assessment, including a history, physical examination, review of laboratory data, and assignment of ASA classification will be performed on all patients prior to the procedure. After premedication with intravenous midazolam 2 mg, patients will be transferred to the operating room.
Standard monitors such as noninvasive blood pressure, electrocardiography (ECG), and pulse oximetry (SpO2) will be attached. Anesthesia will be induced using propofol 1-2 mg/kg, fentanyl 1-2 µg/kg and sevoflurane. After adequate manual ventilation, atracurium 0.5 mg/kg will be administered to facilitate endotracheal intubation. Ventilation will be started with oxygen and medical air (FiO2 = 0.6). Patients will be positioned in the lateral position to perform the ESPB and for preparation for surgery.
Erector SpinaePlane Block technique:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded control study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is able to provide a written informed consent.
- •ASA I-II.
- •Patient is scheduled to perform an elective open renal surgery through a flank incision.
排除标准
- •ASA III-IV
- •Pregnancy.
- •Patient is allergic to bupivacaine local anesthetic.
- •Impaired coagulation (Platelet count< 150,000 cells/mcl and/or INR ≥ 1.4).
- •Infection at site of injection.
- •Prior same side flank surgery.
研究组 & 干预措施
ESPB group
A total of 25 ml bupivacaine 0.5% willbe injected into the ESP.
干预措施: ESPB block (Drug)
Control group
The ESPB will not be performed.
干预措施: control (Other)
结局指标
主要结局
Time to first rescue analgesia
时间窗: 30-45 minutes.
Rescue analgesia with intravenous pethidine (25 mg) will be prescribed if the patient's resting NRS score is more than three or on patient demand. Additional intravenous doses of 25 mg of pethidine will be given if needed to achieve a score below 4. The second rescue analgesic plan will be intravenous ketorolac 30 mg diluted in 100 ml normal saline and administered slowly, if NRS remained persistently \>3 after 15 min of the first rescue analgesic administration.
次要结局
- Postoperative analgesic consumption(over the first 24 hours post operatively.)
- Patient satisfaction(over first 24 hours post operatively.)
研究者
Moshira sayed mohamed
Anesthesia and Intensive care clinical researcher
Theodor Bilharz Research Institute