The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients
- Conditions
- Morbid Obesity
- Interventions
- Procedure: Ultrasound groupProcedure: Landmark group
- Registration Number
- NCT05342922
- Lead Sponsor
- Karaman Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound group Ultrasound group Ultrasound assited technique will be used for spinal anesthesia performance. Landmark group Landmark group Land-mark assisted technique will be used for spinal anesthesia performance.
- Primary Outcome Measures
Name Time Method The success rate of 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 Number of skin punctures 30 minute Skin puncture is defined as any separate skin puncture attempt.
Time taken for spinal injection 30 minute The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Failure rate of spinal anesthesia 120 minute Number of parturients who need additional analgesic drug or conversion to general anesthesia
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
incidence of postoperative headache 72 hour 12-72 hours following spinal anesthesia due to CSF leakage
Incidence of hypotension 2 hour A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
Number of needle pass 30 minute Needle pass is defined as skin puncture plus number of redirection attempts
Number of puncture levels 30 minute Move to a second lumbar space after 3 needle insertion attempts
Patient satisfaction The procedure duration 30 minute Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
incidence of complications during puncture 30 minute Incidence of radicular pain, paresthesia, and blood during spinal needle injection
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ] 20 minute thoracic dermatome level of sensory block assessed by pinprick test
Trial Locations
- Locations (1)
Karaman Training and Research Hospital
🇹🇷Karaman, Turkey