Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients
- Conditions
- Obesity, Morbid
- Interventions
- Device: Landmark method group
- Registration Number
- NCT06410820
- Lead Sponsor
- Karaman Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Landmark method group Landmark method group Land-mark assisted technique will be used for spinal anesthesia performance.
- Primary Outcome Measures
Name Time Method The success rate of the first puncture 30 minute Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
- Secondary Outcome Measures
Name Time Method Time taken for spinal injection 30 minute The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Number of puncture levels 30 minute Move to a second lumbar space after 3 needle insertion attempts
incidence of postoperative headache 72 hours 12-72 hours following spinal anesthesia due to CSF leakage
Failure rate of spinal anesthesia 120 minute Number of parturients who need additional analgesic drug or conversion to general anesthesia
Incidence of hypotension 2 hours A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
dermatome level of sensory block 10 minute thoracic dermatome level of sensory block assessed by pinprick test
The procedure duration time 30 minute The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow
Time interval to determine needle insertion site 30 minute Time interval between the operator touches the parturient and the completion of the needle insertion point marking
Number of needle pass 30 minute Needle pass is defined as skin puncture plus number of redirection attempts
Number of skin punctures 30 minute Skin puncture is defined as any separate skin puncture attempt.
Patient satisfaction The procedure duration 120 minute Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
incidence of complications during puncture 120 minute Incidence of radicular pain, paresthesia, and blood during spinal needle injection
Trial Locations
- Locations (1)
Karaman Training and Research Hospital
🇹🇷Karaman, Turkey