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临床试验/NCT07601542
NCT07601542已完成不适用

Evaluation of Ultrasound Assisted Localisation of the Intervertebral Space Versus the Traditional Landmark Technique During Subarachnoid Block for Caesarean Section in Obese Parturient

Bangladesh Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to evaluate whether the ultrasound-assisted technique improves the accuracy and safety of spinal anesthesia compared to the traditional landmark technique in obese women undergoing a cesarean section. The main questions it aims to answer are:

Does the ultrasound-assisted technique reduce the number of needle attempts required for successful spinal anesthesia? Does the ultrasound-assisted technique decrease the incidence of post-dural puncture headache (PDPH) and chronic low back pain at the needle insertion site? Does the ultrasound-assisted technique reduce procedure time compared to the landmark technique?

Participants will:

Receive spinal anesthesia using either the ultrasound-assisted technique or the traditional landmark technique for cesarean section.

Be monitored for the number of needle attempts, procedure time, and any post-operative complications such as PDPH or low back pain.

Follow up for three months after the procedure to assess any long-term effects, including chronic low back pain and quality of life.

详细描述

This clinical trial is designed to compare two techniques for performing subarachnoid block (SAB) in obese women undergoing elective cesarean sections. The study aims to evaluate the effectiveness and safety of ultrasound-assisted spinal anesthesia versus the traditional landmark-guided technique. Both techniques are commonly used for regional anesthesia, but the effectiveness of ultrasound assistance in improving procedural accuracy, reducing complications, and enhancing the overall success rate in obese parturient has not been sufficiently studied.

Study Design

This is a randomized controlled trial conducted at the Obstetric Operating Theatre of Bangladesh Medical University (BMU). Participants will be randomly assigned to one of two groups: Group A (landmark technique) and Group B (ultrasound-assisted technique). The study will evaluate the following:

Primary Objective:

To assess the number of needle attempts required for successful subarachnoid block in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Elective caesarean section
  • ASA physical status: Ⅱ
  • Obese parturient (BMI ≥ 30.1 kg/m²)

排除标准

  • Allergic to local anaesthetic (0.5% Bupivacaine hydrochloride with 8% Dextrose and 2 % Lidocaine hydrochloride USP)
  • Preexisting neurological deficit by clinical examination
  • Any contraindication to SAB
  • History of scoliosis or spinal instrumentation
  • Allergy to ultrasound transmission gel

研究者

发起方
Bangladesh Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kazi Mahzabin Arin

Assistant Professor

Bangladesh Medical University

研究点 (1)

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