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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06987240
Enrollment
68
Registered
2025-05-23
Start date
2025-05-01
Completion date
2025-11-01
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREUltrasonography-guided combined spinal epidural anesthesia application

patients with BMI\>30

PROCEDURECombined spinal epidural anesthesia with Landmark

Patients with BMI\>30

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First attempt success rateup to 20 weeksFIRST TRY SUCCESS; will be defined as FINDING THE EPIDURAL SPACING WITHOUT REMOVING THE NEEDLE FROM THE SKIN.

Secondary

MeasureTime frameDescription
Number of needle insertionsup to 20 weeksNumber of referrals after needle intervention
Time to determine the needle insertup to 20 weeksDuration of determination of the needle insertion site by ultrasonography or anatomical landmarks
Total procedure timeup to 20 weeksProcedure 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026