CompletedNot Applicable

Comparison of Spinal Anesthesia and Erector Spinae Plane Block in Critically Adult Patients Undergoing Femur Surgery

Turkey (Türkiye)40 participantsStarted 2024-10-20

Plain-language summary

The goal of this observational study is to compare the regional anesthetic methods (not including general anesthesia) -spinal anesthesia, erector spinae plane (ESP) block- which are in routine practice in critically ill adult patients operated for femur fracture, in terms of intraoperative and postoperative hemodynamics and clinical course, postoperative intensive care unit stay and hospitalization durations, pain scores, postoperative morbidity, and mortality. Participants will undergo either spinal anesthesia or erector spinae plane block.

Who can participate

Age range

65 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Agree to participate in the study * Patients older than 65 years of age who are planning to undergo an operation for a femur fracture and who are in the ASA III and above risk group and for whom postoperative intensive care unit follow-up is foreseen * Patients who agree to be operated under regional anesthesia Exclusion Criteria: * Patients who did not want to be included in the study * Patients considered suitable for operation under general anesthesia * Patients allergic to bupivacaine * Patients with contraindications to neuraxial blockage (infection at the injection site, coagulopathy or other bleeding diathesis, severe hypovolemia, increased intracranial pressure, severe aortic stenosis, severe mitral stenosis)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain scores

Timeframe: The VAS scores of the patients will be evaluated preoperatively, at 1 hour, 6 hours, 12 hours and 24 hours postoperatively.

Intraoperative sedation

Timeframe: The total dose of sedatives used along the operation will be calculated one time immediately at the end of the operation

Intensive care unit length of stay

Timeframe: Through study completion, an average of 24 months.The intensive care unit length of stay will be calculated one time at the end of the intensive care unit stay, immediately at the timepoint of intensive care unit discharge.

Hospital length of stay

Timeframe: Through study completion, an average of 24 months.The ihospital length of stay will be calculated one time at the end of the hospital stay, immediately at the timepoint of the hospital discharge.

Complications in the Intensive Care Unit

Timeframe: Complications will be recorded 1 time per day along the intensive care unit stay up to 90th day postoperatively.

Mortality

Timeframe: Mortality will be recorded 4 times up to 90th day postoperatively.: 1- at the time of discharge from the Intensive care unit, 2-at the time of discharge from the hospital 3- on the postoperative 30th day, 4- Mortality on the postoperative90th day

Trial details

NCT IDNCT06652334

SponsorDuzce University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Femoral Fractures trials