"Ultrasound vs. Landmark Technique for Spinal Anesthesia in Obese Women Undergoing Cesarean Section"
NCT07601542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-22
Summary
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.
Conditions
- Cesarean Section
- Obese Parturient
- Ultrasound Guided Subarachnoid Block
Interventions
- PROCEDURE
-
Landmark-Guided Spinal Anesthesia
This intervention involves the use of traditional anatomical landmarks to locate the correct intervertebral space for performing subarachnoid block (SAB). The anesthesiologist identifies the L3-L4 or L4-L5 intervertebral space by palpating the iliac crests and using Tuffier's line as a reference. A 25G Quincke needle is used for SAB, and 0.5% hyperbaric bupivacaine with 25 μg fentanyl is administered. This technique is the standard approach used in many clinical settings for spinal anesthesia.
- PROCEDURE
-
Ultrasound-Assisted Spinal Anesthesia
This intervention utilizes ultrasound guidance to identify the correct intervertebral space for performing subarachnoid block (SAB). A low-frequency (2-5 MHz) curvilinear ultrasound probe is used to visualize the lumbar spine in real-time, ensuring precise identification of the L3-L4 or L4-L5 intervertebral space. The anesthesiologist places the needle based on ultrasound images that show the anatomical structures, such as the spinous processes and interlaminar spaces. The same anesthetic agents (0.5% hyperbaric bupivacaine and 25 μg fentanyl) are administered through a 25G Quincke needle for SAB.
Sponsors & Collaborators
-
Bangladesh Medical University
lead OTHER
Principal Investigators
-
AKM Akhtaruzzaman, MD · Bangladesh Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-01
- Primary Completion
- 2025-08-30
- Completion
- 2025-11-30
Countries
- Bangladesh
Study Locations
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