Obesity, Morbid
Conditions
Keywords
Spinal Anesthesia, Cesarean Delivery, Ultrasound
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.
Interventions
DEVICEProcedure/Surgery: Ultrasound method group
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.
DEVICELandmark method group
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.
Sponsors
Karaman Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of skin punctures | 30 minute | Skin puncture is defined as any separate skin puncture attempt. |
| Number of needle pass | 30 minute | Needle pass is defined as skin puncture plus number of redirection attempts |
| 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 |
| 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 |
| 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 |
| incidence of postoperative headache | 72 hours | 12-72 hours following spinal anesthesia due to CSF leakage |
| Incidence of hypotension | 2 hours | A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg |
| Failure rate of spinal anesthesia | 120 minute | Number of parturients who need additional analgesic drug or conversion to general anesthesia |
| dermatome level of sensory block | 10 minute | thoracic dermatome level of sensory block assessed by pinprick test |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAyşegül Bilge, MD
Karaman TRH
Outcome results
None listed