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Not yet recruiting NCT06191445

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

No phase Interventional Spinal Anesthesia Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conventional Landmark Technique, Ultrasound Assisted Technique, Real-Time Ultrasound Guided Technique.
Who it may be relevant to
Registry conditions: Spinal Anesthesia, Ultrasound. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

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

Primary outcome measures

  • Success rates on the first attempt. [Time frame: Preoperatively]
Secondary outcome measures (1)
  • Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction [Time frame: Preoperatively]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Bursa Uludag University Faculty of Medicine — Bursa

Identifiers

NCT: NCT06191445 · UludagU-KCebeci-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗