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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines. When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.
In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.
Karaman Training and Research Hospital
Karaman, Turkey (Türkiye)
RECRUITINGThe success rate of the first puncture
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
Time frame: 30 minute
Number of skin punctures
Skin puncture is defined as any separate skin puncture attempt.
Time frame: 30 minute
Number of needle pass
Needle pass is defined as skin puncture plus number of redirection attempts
Time frame: 30 minute
The procedure duration time
The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow
Time frame: 30 minute
Time interval to determine needle insertion site
Time interval between the operator touches the parturient and the completion of the needle insertion point marking
Time frame: 30 minute
Time taken for spinal injection
The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Time frame: 30 minute
Number of puncture levels
Move to a second lumbar space after 3 needle insertion attempts
Time frame: 30 minute
Patient satisfaction The procedure duration
Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
Time frame: 120 minute
incidence of complications during puncture
Incidence of radicular pain, paresthesia, and blood during spinal needle injection
Time frame: 120 minute
incidence of postoperative headache
12-72 hours following spinal anesthesia due to CSF leakage
Time frame: 72 hours
Incidence of hypotension
A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
Time frame: 2 hours
Failure rate of spinal anesthesia
Number of parturients who need additional analgesic drug or conversion to general anesthesia
Time frame: 120 minute
dermatome level of sensory block
thoracic dermatome level of sensory block assessed by pinprick test
Time frame: 10 minute
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