Evaluating the Intraoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block in Parturient Undergoing Elective Cesarean Section for Placenta Accreta Under General Anesthesia; a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total intraoperative fentanyl consumption
研究概览
简要总结
Due to the significant risk of massive bleeding complicated by profound hypotension and coagulopathy and a high likelihood of hysterectomy during caesarean delivery, general anesthesia is generally regarded as the anesthetic of choice for patients with placenta accreta. The advantage of a planned general anesthetic is the ability to secure the airway in a controlled setting, before the onset of hemodynamic instability, airway edema or coagulopathy. A multidisciplinary approach may improve patient outcomes. However, it is necessary to maintain a good depth of anesthesia and sufficient analgesia and to consider the impact of anesthesia drugs on the fetus.
Since all opioids, particularly those with high lipid solubility (e.g., remifentanil, fentanyl, and sufentanil), readily pass through the placenta to the fetus. Consequently, opioid administration is usually avoided until after delivery to reduce the risk of neonatal depression.
The latest publications have reported that the erector spinae plane block is one of the components of multimodal analgesia techniques for pain management after different surgical procedures, including cesarean delivery.
详细描述
All included subjects will be randomly allocated using sequentially numbered, sealed opaque envelope technique. into two groups; (Group A): will receive preoperative ultrasound guided erector spinae plane block and (Group B): will receive fentanyl bolus(1mic/kg) following delivery of the fetus (conventional group).
There will neither be restrictions nor stratification in the randomization process. The allocation envelope will be opened by the anesthetist who will perform the block while another anesthetist who will be blinded of the intervention will be responsible for data collection both intra and post-operative.
- Pre-operative preparation All patients will be anaesthetized in accordance with the local policy of Cairo university gynecology & obstetrics hospital. Except for oral clear fluid intake 3 hours before surgery, all patients will be instructed to fast for 6 hours. Patients will be transferred to the preparation room one hour before surgery to record their demographic data and allocate them to either group.
(Group A)
Patients in this anesthetic group, bilateral ESPB will be performed under ultrasound guidance by an anesthesiologist in the preparation room thirty minutes before induction of general anesthesia in the following steps:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status II.
- •Female patients aged 18 to 40 years' old.
- •BMI less than
- •Diagnosed placenta accreta
排除标准
- •• Patient's unwillingness to participate in the study.
- •Contraindication to receive regional anesthesia.
- •Patients with anticipated difficult airway.
- •Allergy to any of the drugs used in the study
- •Any apparent deformity in the spine.
- •Hemodynamic instability.
- •Fetal distress.
- •Surgically complicated cases.
研究组 & 干预措施
Erector Spinae block .
bilateral ESPB with general anesthesia. block will be performed under ultrasound guidance 30 minutes before induction of general anesthesia . After standard disinfection of skin and subcutaneous infiltration of 3 mL of 2% lidocaine, a 22G blunt needle will be introduced from the outside towards the transverse process (T9) using the in-plane method until the needle tip crosses all the muscles. Subsequently, 20 ml of 0.25% Bupivacaine will be injected between the transverse process and the deep surface of the erector spinae on each side.
thus the expected dermatomal block would be from T5 to L1. Testing for loss of tactile sensation and discrimination in the expected dermatome will be done 20 min after the injection of drugs. If no loss of sensation was attained within 30 min this will be considered an unsuccessful block and the parturient will be excluded from the study and managed according to the theater protocol.
干预措施: ultra sound guided Erector spinae plane block (Procedure)
general anesthesia
general anesthesia with opioids. Patients in this group will be given 1mic/kg fentanyl diluted to 10 ml by IV injection by the attending anesthetist after delivery of the fetus. General anesthesia will be induced in both groups after adequate preoxygenation using propofol 2.5 mg/kg, rocuronium 1 mg/kg. After securing the endotracheal tube (6.5mm), anesthesia will be maintained using 1 MAC isoflurane, timed rocuronium and volume-controlled ventilation 6-8ml/kg to obtain normocarbia.
干预措施: ultra sound guided Erector spinae plane block (Procedure)
结局指标
主要结局
Total intraoperative fentanyl consumption
时间窗: the whole procedure
total dose of fentanyl consumed intraoperative
次要结局
- The time to first request of rescue analgesia(24 hours)
- Visual analog scale (VAS) at 2 h, 6 h, 12 h, and 24 h after operation(24 hours)
研究者
Amany Ahmed Eissa
lecturer of anesthesia& ICU
Kasr El Aini Hospital