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临床试验/NCT03747406
NCT03747406已完成不适用

Comparison Between Ultrasound-guided Erector Spinae Block and Transverse Abdominis Plane Block in Obese Patients Undergoing Sleeve Gasterectomy.

Dalia Ismail1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年12月1日最近更新:
适应症

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

  1. 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.
  2. 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.
  3. Duration of surgery (from skin incision till skin closure) and general anesthesia (from induction of GA till extubation).
  4. 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

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.

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

发起方
Dalia Ismail
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dalia Ismail

Lecturer of Anaesthesia- Cairo University

Cairo University

研究点 (1)

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