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

Not Applicable

Not yet recruiting

• Conditions: Spinal Anesthesia; Ultrasound
• Interventions: Procedure: Real-Time Ultrasound Guided Technique; Procedure: Conventional Landmark Technique; Procedure: Ultrasound Assisted Technique

• Registration Number: NCT06191445
• Lead Sponsor: Uludag University

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

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Study Start: 2024-11-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-RTG Group	Real-Time Ultrasound Guided Technique	The investigator will perform spinal anesthesia using real-time ultrasound-guided technique.
Conventional Landmark Group	Conventional Landmark Technique	The investigator will perform spinal anesthesia using the conventional landmark technique.
USAS Group	Ultrasound Assisted Technique	The investigator will perform spinal anesthesia using ultrasound-assisted technique.

Primary Outcome Measures

Name	Time	Method
Success rates on the first attempt.	Preoperatively	The primary outcome is to compare the success rates on the first attempt.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Bursa Uludag University Faculty of Medicine; 🇹🇷 Bursa, Turkey