Spinal Anesthesia, Ultrasound
Conditions
Keywords
Anesthesia, Spinal Anesthesia, Obesity, Ultrasonography
Brief summary
Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.
Detailed description
Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg/m² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
Interventions
PROCEDUREConventional Landmark Technique
The investigator will perform spinal anesthesia using the conventional landmark technique.
PROCEDUREUltrasound Assisted Technique
The investigator will perform spinal anesthesia using the ultrasound assisted technique.
PROCEDUREReal-Time Ultrasound Guided Technique
The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.
Sponsors
Uludag University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Patients who will undergo lower extremity orthopedic surgery * ASA I-II-III patients * BMI 30 kg/m² and above
Exclusion criteria
* BMI \< 30 kg/m² * ASA IV-V patients * Severe cardiovascular disease * Patients with a known or suspected allergy to local anesthetics * Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rates on the first attempt. | Preoperatively | The primary outcome is to compare the success rates on the first attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction | Preoperatively | The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications (radicular pain, postdural puncture headache, hematoma, paresthesia) and patient satisfaction. Needle redirection was defined as any change in needle insertion trajectory not involving complete withdrawal of the needle from the patient's skin. Procedure time was defined as the total duration from the placement of the probe on the skin to the completion of skin marking and from the insertion of the needle into the skin to the observation of cerebrospinal fluid (CSF) outflow using the designated technique. Patient satisfaction will be evaluated on a scale of 1 to 5 (1:extremely unsatisfied; 5:extremely satisfied). |
Countries
Turkey (Türkiye)
Outcome results
None listed