Clinical trial NCT06410820: Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients
Official title: Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI ≥ 50 kg/m2. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Keywords: Spinal Anesthesia
Cesarean Delivery
Ultrasound
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The success rate of the first puncture
timeFrame: 30 minute
Secondary outcomes:
measure: Number of skin punctures
timeFrame: 30 minute
measure: Number of needle pass
timeFrame: 30 minute
measure: The procedure duration time
timeFrame: 30 minute
measure: Time interval to determine needle insertion site
timeFrame: 30 minute
measure: Time taken for spinal injection
timeFrame: 30 minute
measure: Number of puncture levels
timeFrame: 30 minute
measure: Patient satisfaction The procedure duration
timeFrame: 120 minute
measure: incidence of complications during puncture
timeFrame: 120 minute
measure: incidence of postoperative headache
timeFrame: 72 hours
measure: Incidence of hypotension
timeFrame: 2 hours
measure: Failure rate of spinal anesthesia
timeFrame: 120 minute
measure: dermatome level of sensory block
timeFrame: 10 minute
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman TRH
name: Ayşegül Bilge, MD
role: PRINCIPAL_INVESTIGATOR
References: