Comparison Between Real-Time Ultrasound Guidance vs Anatomical Landmark Technique on the Efficacy of Paramedian Spinal Anaesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- success rate of spinal needle insertion
Study Overview
Brief Summary
The purpose of this study is to compare the clinical efficacy of real-time ultrasound guidance on spinal anesthesia vs the traditional anatomical landmark technique, by comparing success rate of spinal needle insertion, success rate rate of single needle pass, duration and immediate complications.
Detailed Description
Research hypothesis
- Ultrasound guidance will lead to a significantly different success rate of paramedian spinal needle insertion, as well as the success rate of single-needle-pass when patient lying in lateral position.
- Ultrasound guidance of paramedian spinal anaesthesia has a different rate of complication of spinal anaesthesia, e.g. postdural puncture headache and bloody taps.
- Ultrasound guidance of paramedian spinal anaesthesia will cause a significant different in duration of giving spinal anaesthesia, compared to non ultrasound guided technique.
Justification of the Study
Ultrasound guidance in neuraxial blockade has been shown to be superior to palpation in correctly identifying lumbar intervertebral level, as well as improve efficiency and reduce complication of spinal anaesthesia.
Paramedian approach to the subarachnoid spaces is useful in situations where the patient's anatomy does not favor the midline approach, e.g., inability to flex the spine or heavily calcified interspinous ligaments. Studies have shown that choice of midline or paramedian approach did not affect the success rate of the subarachnoid puncture in general. Therefore, this is a technique that worth to be studied.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consented adults aged at least 18 years old.
- •ASA I to III.
- •Presented for lower limb surgery.
- •Fasted for at least 6 hours.
Exclusion Criteria
- •Patient refusal
- •Contraindication to neuraxial block.
- •Patient on anticoagulant medication, or coagulopathy (INR > 1.5)
- •Patient on double antiplatelet, or thrombocytopenia (platelet < 100)
- •Local infection at site of injection
- •Indeterminate neurological disease
- •Allergy to local anaesthetics
- •Spinal abnormality
- •Pregnancy.
- •Previous surgery to lumbar region.
- •BMI > 30
Arms & Interventions
Anatomical Landmark Technique
Traditional anatomical landmark technique based paramedian spinal anesthesia
Intervention: Anatomical Landmark Technique (Procedure)
Real-time Ultrasound-guided Technique
Ultrasound-guided paramedian spinal anesthesia Intervention: Ultrasound-guided Technique
Intervention: Real-time Ultrasound-guided (Procedure)
Outcomes
Primary Outcomes
success rate of spinal needle insertion
Time Frame: during the procedure of spinal anesthesia
The ability of getting a successful spinal anesthesia with a single skin puncture regardless of needle redirection.
success rate of single needle pass
Time Frame: during the procedure of spinal anesthesia
The ability of getting a successful spinal anesthesia with a single skin puncture and no needle redirection.
Secondary Outcomes
- duration of procedure(during the procedure of spinal anesthesia)
- immediate complication(immediately after and within 1 week after given spinal anesthesia)
Investigators
Soon Eu Chong
Medical Lecturer in Anesthesiology
Universiti Sains Malaysia