Landmark vs Ultrasound For Combined Spinal Epidural

Comparison Of Ultrasound-Assisted Combined Spinal Epidural Procedure With Anatomical Landmark Method In Obese Patients Undergoing Lower Extremity Surgery

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Combined Spinal Epidural Anesthesia; Obesity (Body Mass Index >30 kg/m2)
• Intervention / Treatment: Procedure: Ultrasonography-guided combined spinal epidural anesthesia application; Procedure: Combined spinal epidural anesthesia with Landmark

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Adapazarı
    • Sakarya, Adapazarı, Turkey (Türkiye), 54100
      • Sakarya University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ultrasonography (USG); 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; patients with BMI>30
Placebo Comparator: Landmark (L); 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; Patients with BMI>30

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of needle insertions	Number of referrals after needle intervention	up to 20 weeks
Time to determine the needle insert	Duration of determination of the needle insertion site by ultrasonography or anatomical landmarks	up to 20 weeks
Total procedure time	Procedure time: The time from the entry of the Tuohy needle through the skin to the completion of the procedure, placement of the catheter and withdrawal of the needle	up to 20 weeks

Collaborators and Investigators

• Sponsor: Sakarya University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): November 1, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 23, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2025-SEAH-BC-KSEA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No