NCT06191445

Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients

Does the Use of Ultrasound Increase Spinal Anesthesia Success for Obese Patients?: Evaluation of the Success of Spinal Anesthesia Administered with Real-Time Ultrasound-Guided, Ultrasound-Assisted and Conventional Landmark Techniques

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Uludag University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spinal Anesthesia
• Ultrasound

Interventions

Type	Name	Description
PROCEDURE	Conventional Landmark Technique	The investigator will perform spinal anesthesia using the conventional landmark technique.
PROCEDURE	Ultrasound Assisted Technique	The investigator will perform spinal anesthesia using the ultrasound assisted technique.
PROCEDURE	Real-Time Ultrasound Guided Technique	The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-06-15
• Completion: 2025-08-01
• First posted: 2024-01-05
• Last updated: 2024-10-16

Locations

1 site across 1 country: Turkey (Türkiye)