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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Landmark Group | Active Comparator | The investigator will perform spinal anesthesia using the conventional landmark technique. |
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| USAS Group | Active Comparator | The investigator will perform spinal anesthesia using ultrasound-assisted technique. |
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| US-RTG Group | Active Comparator | The investigator will perform spinal anesthesia using real-time ultrasound-guided technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Landmark Technique | Procedure | The investigator will perform spinal anesthesia using the conventional landmark technique. |
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| Measure | Description | Time Frame |
|---|---|---|
| Success rates on the first attempt. | The primary outcome is to compare the success rates on the first attempt. | Preoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Uludag University Faculty of Medicine | Bursa | 16059 | Turkey (Türkiye) |
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| Ultrasound Assisted Technique | Procedure | The investigator will perform spinal anesthesia using the ultrasound assisted technique. |
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| Real-Time Ultrasound Guided Technique | Procedure | The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique. |
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| Preoperatively |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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