Clinical trial NCT05342922: The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Spinal Anesthesia
Cesarean Delivery
Ultrasound
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 80
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: The success rate of 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: 30 minute
measure: incidence of complications during puncture
timeFrame: 30 minute
measure: incidence of postoperative headache
timeFrame: 72 hour
measure: Incidence of hypotension
timeFrame: 2 hour
measure: Failure rate of spinal anesthesia
timeFrame: 120 minute
measure: dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]
timeFrame: 20 minute
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Betul Basaran, MD,DESA
role: STUDY_DIRECTOR
References: