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临床试验/NCT06707571
NCT06707571尚未招募不适用

Ultrasongraphy Guided Spinal Anesthesia Versus Landmark in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial

Assiut University0 个研究点目标入组 52 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
the first-pass success rate of Combined spinal-epidural anesthesia

研究概览

简要总结

Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and the need to minimize postoperative complications. Two approaches to administering spinal anesthesia are Ultrasound (US)-guided and the traditional landmark-based technique.

the aim of the study :To evaluate the efficacy, safety and feasibility of US-guided spinal anesthesia versus the landmark-based technique in cancer patients undergoing lower abdominal surgery.

详细描述

The traditional landmark method relies on palpating anatomical structures, such as the iliac crests and spinal processes, to guide needle insertion. Although widely used, it can be challenging in patients with anatomical variations, obesity, or previous surgeries, potentially leading to multiple attempts, increased patient discomfort, or complications. On the other hand, Ultrasound (US) imaging has become an increasingly popular tool among anesthesiologists to guide neuraxial blockade. US-guided spinal anesthesia provides real-time visualization of the relevant anatomy, including the spinal canal, ligaments, and surrounding tissues, enabling more accurate needle placement. This technique has gained attention for its potential to improve success rates, reduce complications, and enhance patient comfort, particularly in complex cases such as cancer patients, where precision is vital.

By examining factors such as procedural success rates, patient comfort, complication rates, and overall outcomes, we can better understand the role of ultrasound guidance in optimizing anesthetic care for this vulnerable patient population.

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

Patients will be randomly assigned to receive spinal anesthesia using the surface landmark-guided (landmark group) or preprocedural ultrasound-assisted (ultrasound group) technique using a computer-generated table of random numbers. Group allocation will be concealed by sequentially numbered, sealed opaque envelopes, which are opened only by the attending anesthesiologist immediately before the procedure.

入排标准

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

入选标准

  • •Age >18 years old
  • •patients with a body mass index (BMI) of 18-40 kg/m2
  • •American Society of Anesthesiologists (ASA) physical status classification of I to III.

排除标准

  • •• Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
  • •Failed or unsatisfactory intrathecal block.
  • •Patients with known hypersensitivity to amide local anesthetics.
  • •Local injection site infection or spinal deformity.
  • •Severe hypotension.
  • •Space occupying lesions of the brain.
  • •Hypovolemia.
  • •Pregnancy.

研究组 & 干预措施

Landmark Group

Experimental

patients will receive spinal anesthesia using the surface landmark-guided

干预措施: spinal anesthesia (Procedure)

Ultrasonography Group

Experimental

patients will receive spinal anesthesia after us-assisted technique

干预措施: spinal anesthesia (Procedure)

结局指标

主要结局

the first-pass success rate of Combined spinal-epidural anesthesia

时间窗: baseline

first-pass success was defined as the needle reaching the subarachnoid space within a single insertion attempt, without redirection

次要结局

未报告次要终点

研究者

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

Maram Ashraf Zahr Eldeen

Anesthesia, Intensive Care and Pain Management Department South Egypt cancer Institute

Assiut University

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