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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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

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Spinal Anesthesia Ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Conventional Landmark Group

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

Group Type ACTIVE_COMPARATOR

Conventional Landmark Technique

Intervention Type PROCEDURE

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

USAS Group

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

Group Type ACTIVE_COMPARATOR

Ultrasound Assisted Technique

Intervention Type PROCEDURE

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

US-RTG Group

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

Group Type ACTIVE_COMPARATOR

Real-Time Ultrasound Guided Technique

Intervention Type PROCEDURE

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

Interventions

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Conventional Landmark Technique

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

Intervention Type PROCEDURE

Ultrasound Assisted Technique

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

Intervention Type PROCEDURE

Real-Time Ultrasound Guided Technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No