Landmark vs Ultrasound For Combined Spinal Epidural

NCT ID: NCT06987240

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Ultrasonography-guided combined spinal epidural anesthesia application

Intervention Type PROCEDURE

patients with BMI\>30

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.

Group Type PLACEBO_COMPARATOR

Combined spinal epidural anesthesia with Landmark

Intervention Type PROCEDURE

Patients with BMI\>30

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasonography-guided combined spinal epidural anesthesia application

patients with BMI\>30

Intervention Type PROCEDURE

Combined spinal epidural anesthesia with Landmark

Patients with BMI\>30

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sakarya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sakarya University Hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-SEAH-BC-KSEA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound High BMI Study
NCT05052658 COMPLETED NA
Ultrasound for Neuraxial Anesthesia
NCT02553746 COMPLETED NA