Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- The success rate of first puncture
Study Overview
Brief Summary
This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.
The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.
Detailed Description
Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.
Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Triple (Participant,Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Parturient who will receive selective cesarean delivery under spinal anesthesia
- •ASA 2-3 scheduled for elective sections
- •BMI≥40 kg/m2
- •normal singleton pregnancy
- •≥37 weeks of gestation
Exclusion Criteria
- •Multiple gestations
- •Emergency C-section
- •exist contraindications of spinal anesthesia
- •Local anesthetics allergy
- •BMI<40 kg/m2
- •history of lumbar spinal diseases and lumbar surgery
- •Parturient refusal
Outcomes
Primary Outcomes
The success rate of first puncture
Time Frame: 30 minute
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
Secondary Outcomes
- Number of skin punctures(30 minute)
- Time taken for spinal injection(30 minute)
- Failure rate of spinal anesthesia(120 minute)
- The procedure duration time(30 minute)
- Time interval to determine needle insertion site(30 minute)
- incidence of postoperative headache(72 hour)
- Incidence of hypotension(2 hour)
- Number of puncture levels(30 minute)
- Number of needle pass(30 minute)
- Patient satisfaction The procedure duration(30 minute)
- incidence of complications during puncture(30 minute)
- dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ](20 minute)