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

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06191445
• Other study ID #: UludagU-KCebeci-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: May 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Anesthesia
• Ultrasound

Intervention

Procedure:
• Conventional Landmark Technique
The investigator will perform spinal anesthesia using the conventional landmark technique.
• Ultrasound Assisted Technique
The investigator will perform spinal anesthesia using the ultrasound assisted technique.
• Real-Time Ultrasound Guided Technique
The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University Faculty of Medicine	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rates on the first attempt.	The primary outcome is to compare the success rates on the first attempt.	Preoperatively
Secondary	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