Evaluation of Ultrasound Assisted Localisation of the Intervertebral Space Versus the Traditional Landmark Technique During Subarachnoid Block for Caesarean Section in Obese Parturient
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective caesarean section
- •ASA physical status: Ⅱ
- •Obese parturient (BMI ≥ 30.1 kg/m²)
Exclusion Criteria
- •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
Investigators
Kazi Mahzabin Arin
Assistant Professor
Bangladesh Medical University