Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Cumulative opioid consumption during the first 24 h postoperatively
研究概览
简要总结
assess the efficacy of ultrasound guided erector spinae block to decrease the requirement for analgesics after laparoscopic sleeve gastrectomy and to decrease postoperative pain scores and opioid consumption compared to subcostal transverses abdominis block.
详细描述
Primary outcomes
• Cumulative opioid consumption during the first 24 h postoperatively. For the purpose of comparison, all opioids administered postoperatively will be converted to IV morphine equivalent doses using standard opioid dosage conversion tables.
Secondary outcome parameters
- Pain assessment by the aid of Visual analogue scale (VAS), which is consisted of a "10 cm" line with one end labeled no pain and other end labeled worst intolerable pain. The patients marked the line at the point that best describing the pain intensity. The preoperative assessment included training of the patients about (VAS) for postoperative pain. The length of the line to the patient's mark will be measured and recorded postoperative after 30 min., 4, 6, 8, and 24 hours.
- Failure rate of the block will be calculated, where the block will be considered a failed block if the patient requires more than two doses of rescue analgesia in the first hour postoperatively.
- Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
- Incidence of complications, such as: Nerve injury, Hematoma formation, LA toxicity, and intravascular injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients from 18 to 59 years.
- •BMI > 40 kg/m2
- •Genders eligible for study: both.
- •ASA I-III.
- •No contraindications for application of regional anesthesia as Patient refusal, local anesthetic allergy, local sepsis or infection at puncture site, INR > 1.5 or < 12 hours post LMWH.
排除标准
- •• Patient refusal.
- •Extremes of age.
- •Increased intracranial pressure.
- •Coagulopathy or thrombocytopenia less than 100000/ml.
- •Sepsis (increased risk of meningitis).
- •Infection at the puncture site.
- •Pre-existing neurologic disease.
- •History of allergy to local anesthetic.
研究组 & 干预措施
ESP group
The patient rolled to his side, the level between T9 and T10 identified using ultrasound. An 8-14 MHz curved array probe (Siemens ACUSON X300 Ultrasound System) will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced inplane until contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration confirmed. The same procedure will be repeated in the contralateral side.
干预措施: Erector spinae plane block (Procedure)
TAP group
The patient in supine position. Under complete aseptic conditions, a linear array transducer 5-12 MHz (Siemens ACUSON X300 Ultrasound System) will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers.
干预措施: TAP block (Procedure)
opioid group
will receive intravenous morphine with general anesthesia and total opioid consumption will be calculated
结局指标
主要结局
Cumulative opioid consumption during the first 24 h postoperatively
时间窗: 24 hours after surgery
measure total opioid dose in 24 hours after surgery
次要结局
- pain assessment by Visual Analog Scale(24 hours after surgery)
研究者
Dalia Ismail
Lecturer of Anaesthesia- Cairo University
Cairo University