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

NCT06191445 | Not Yet Recruiting

• 1 other identifier: UludagU-KCebeci-002
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Anesthesia; Ultrasound

Keywords

Anesthesia; Spinal Anesthesia; Obesity; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Success rates on the first attempt.

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

  Preoperatively

Secondary Outcomes (1)

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

  Preoperatively

Study Arms (3)

Conventional Landmark Group

ACTIVE COMPARATOR

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

Procedure: Conventional Landmark Technique

USAS Group

ACTIVE COMPARATOR

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

Procedure: Ultrasound Assisted Technique

US-RTG Group

ACTIVE COMPARATOR

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

Procedure: Real-Time Ultrasound Guided Technique

Interventions

Conventional Landmark Technique PROCEDURE

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

Conventional Landmark Group

Ultrasound Assisted Technique PROCEDURE

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

USAS Group

Real-Time Ultrasound Guided Technique PROCEDURE

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

US-RTG Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Patients who will undergo lower extremity orthopedic surgery
• ASA I-II-III patients
• BMI 30 kg/m² and above

You may not qualify if:

• 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)

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Bursa Uludag University Faculty of Medicine

Bursa, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: November 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: August 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

TU (1)