Landmark vs Ultrasound For Combined Spinal Epidural

NCT06987240 | Completed

• 1 other identifier: 2025-SEAH-BC-KSEA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery. 60 obese patients aged 40-80, ASA II-III, BMI\>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at Sakarya University Medical Faculty Education and Research Hospital will be included in the study. General anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. When placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound. Patients will be divided into two different groups as Anatomical Marking or Ultrasound. Patients in the Ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with Ultrasound in the block room. Patients in the Anatomical Marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination. After determining the needle entry site, patients in both groups will undergo the Combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.

Conditions

Obesity (Body Mass Index >30 kg/m2); Ultrasonography; Combined Spinal Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  FIRST TRY SUCCESS; will be defined as FINDING THE EPIDURAL SPACING WITHOUT REMOVING THE NEEDLE FROM THE SKIN.

  up to 20 weeks

Secondary Outcomes (3)

• Number of needle insertions

  up to 20 weeks

• Time to determine the needle insert

  up to 20 weeks

• Total procedure time

  up to 20 weeks

Study Arms (2)

ultrasonography (USG)

ACTIVE COMPARATOR

In this group, patients will first be marked with ultrasonography and the time required for this procedure will be recorded. Then, the needle will be inserted from the marked area. When performing the combined spinal epidural procedure, the number of needle insertions, the number of directions will be recorded and the time from needle insertion to needle exit will be recorded.

Procedure: Ultrasonography-guided combined spinal epidural anesthesia application

Landmark (L)

PLACEBO COMPARATOR

Patients in this group will be marked according to anatomical landmarks. The time from needle entry to exit and the number of needle entries and directions will be recorded.

Procedure: Combined spinal epidural anesthesia with Landmark

Interventions

Ultrasonography-guided combined spinal epidural anesthesia application PROCEDURE

patients with BMI\>30

ultrasonography (USG)

Combined spinal epidural anesthesia with Landmark PROCEDURE

Patients with BMI\>30

Landmark (L)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA II-III
• BMI\>30
• Elective orthopedic lower extremity surgery
• Combined spinal epidural anesthesia (CSEA)

You may not qualify if:

• Patients with CSEA contraindication
• ASA IV-V
• Diagnosed with scoliosis
• Patients with anatomical disorders
• Patients who did not agree to participate in the study
• Patients for whom follow-up conditions could not be met

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Hospital

Sakarya, Adapazarı, 54100, 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 23, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TU (1)