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OpenTrials
Completed

NCT Number: NCT06987240

Landmark vs Ultrasound For Combined Spinal Epidural

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University Hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasonography-guided combined spinal epidural anesthesia application

Procedure

patients with BMI>30

Combined spinal epidural anesthesia with Landmark

Procedure

Patients with BMI>30

Primary outcomes

  1. First attempt success rate

    Time frame: up to 20 weeks

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

Secondary outcomes

  1. Number of needle insertions

    Time frame: up to 20 weeks

    Number of referrals after needle intervention

  2. Time to determine the needle insert

    Time frame: up to 20 weeks

    Duration of determination of the needle insertion site by ultrasonography or anatomical landmarks

  3. Total procedure time

    Time frame: up to 20 weeks

    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

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Nov 28, 2025

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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