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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Anesthesia; Ultrasound
• Intervention / Treatment: Procedure: Conventional Landmark Technique; Procedure: Ultrasound Assisted Technique; Procedure: Real-Time Ultrasound Guided Technique

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 Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16059
    • Bursa Uludag University Faculty of Medicine
    • Contact: SELCAN AKESEN; Phone Number: +902242953274; Email: selcanakesen@uludag.edu.tr
    • Contact: Kübra Cebeci

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Landmark Group; The investigator will perform spinal anesthesia using the conventional landmark technique.	Procedure: Conventional Landmark Technique; The investigator will perform spinal anesthesia using the conventional landmark technique.
Active Comparator: USAS Group; The investigator will perform spinal anesthesia using ultrasound-assisted technique.	Procedure: Ultrasound Assisted Technique; The investigator will perform spinal anesthesia using the ultrasound assisted technique.
Active Comparator: US-RTG Group; The investigator will perform spinal anesthesia using real-time ultrasound-guided technique.	Procedure: Real-Time Ultrasound Guided Technique; The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rates on the first attempt.	The primary outcome is to compare the success rates on the first attempt.	Preoperatively

Secondary Outcome Measures

Outcome Measure	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).	Preoperatively

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Anesthesia; Ultrasonography; Spinal Anesthesia
• Other Study ID Numbers: UludagU-KCebeci-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No