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NCT Number: NCT06191445

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

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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Key information

Conditions

Spinal Anesthesia Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University Faculty of Medicine

Bursa, 16059, Turkey (Türkiye)

Location contact

Kübra Cebeci

CONTACT

SELCAN AKESEN

CONTACT

[email protected]

+902242953274

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional Landmark Technique

Procedure

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

Ultrasound Assisted Technique

Procedure

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

Real-Time Ultrasound Guided Technique

Procedure

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

Primary outcomes

  1. Success rates on the first attempt.

    Time frame: Preoperatively

    The primary outcome is to compare the success rates on the first attempt.

Secondary outcomes

  1. Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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