Landmark vs Ultrasound For Combined Spinal Epidural

Sakarya University

Status: Completed

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

Treatments: Procedure: Ultrasonography-guided combined spinal epidural anesthesia application; Procedure: Combined spinal epidural anesthesia with Landmark

Study type: Interventional

Funder types: Other

Identifiers

NCT06987240

2025-SEAH-BC-KSEA

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups, including a placebo group

ultrasonography (USG)

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasonography-guided combined spinal epidural anesthesia application

Landmark (L)

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Combined spinal epidural anesthesia with Landmark