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

ConditionsSpinal AnesthesiaUltrasound
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUludag University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years and older

Patients who will undergo lower extremity orthopedic surgery

ASA I-II-III patients

BMI 30 kg/m² and above

Disqualifiers

BMI < 30 kg/m²

ASA IV-V patients

Severe cardiovascular disease

Patients with a known or suspected allergy to local anesthetics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Landmark Technique

    Procedure/Surgery

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

  • Ultrasound Assisted Technique

    Procedure/Surgery

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

  • Real-Time Ultrasound Guided Technique

    Procedure/Surgery

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

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Conventional Landmark GroupActive comparator 1 intervention
Group B: USAS GroupActive comparator 1 intervention
Group C: US-RTG GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Success rates on the first attempt.

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

Time frame
Preoperatively

Secondary outcomes

1

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).

Time frame
Preoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uludag University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: