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

Bursa Uludag University

Status: Not yet enrolling

Conditions: Spinal Anesthesia; Ultrasound

Treatments: Procedure: Ultrasound Assisted Technique; Procedure: Conventional Landmark Technique; Procedure: Real-Time Ultrasound Guided Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06191445

UludagU-KCebeci-002

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 3 patient groups

Conventional Landmark Group

Active Comparator group

Description:

The investigator will perform spinal anesthesia using the conventional landmark technique.

Treatment:

Procedure: Conventional Landmark Technique

USAS Group

Active Comparator group

Description:

The investigator will perform spinal anesthesia using ultrasound-assisted technique.

Treatment:

Procedure: Ultrasound Assisted Technique

US-RTG Group

Active Comparator group

Description:

The investigator will perform spinal anesthesia using real-time ultrasound-guided technique.

Treatment:

Procedure: Real-Time Ultrasound Guided Technique