Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients

Karaman Training and Research Hospital

Status: Enrolling

Conditions: Obesity, Morbid

Treatments: Device: Procedure/Surgery: Ultrasound method group; Device: Landmark method group

Study type: Interventional

Funder types: Other

Identifiers

NCT06410820

11-2022/03

Details and patient eligibility

About

This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section.

The primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.

Full description

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese (BMI ≥ 50 kg/m2) pregnant women.

The manual palpation technique, preferred in neuraxial anesthesia, may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients.

This study will be 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. 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 60 ultrasound-guided neuraxial blocks.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parturient who will receive selective cesarean delivery under spinal anesthesia

• ASA 3 scheduled for elective sections

• BMI≥50 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<50 kg/m2
• History of lumbar spinal diseases and lumbar surgery
• Parturient refusal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ultrasound method group

Active Comparator group

Description:

The ultrasound-assisted technique will be used for spinal anesthesia performance.

Treatment:

Device: Procedure/Surgery: Ultrasound method group

Landmark method group

Experimental group

Description:

Land-mark assisted technique will be used for spinal anesthesia performance.

Treatment:

Device: Landmark method group