Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures (NCT07272226) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures
Turkey (Türkiye)50 participantsStarted 2023-09-15
Plain-language summary
This randomized study aims to compare the efficacy and hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. Conducted at a single center, the study includes 60 patients aged 18 to 90, classified as ASA I-IV, and evaluates anesthesia methods' impact on intraoperative parameters, including blood pressure, sedation needs, and recovery outcomes. The findings will inform anesthetic strategy selection based on patient characteristics and surgical requirements.
Who can participate
Age range
18 Years – 90 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:
* Age between 18 and 90 years.
* American Society of Anesthesiologists (ASA) classification I-IV.
* Scheduled for femoral neck fracture surgery.
* Provided informed consent to participate in the study.
Exclusion Criteria:
* History of allergy to local anesthetics.
* Presence of coagulopathy or bleeding disorders.
* Mental health disorders impairing consent or cooperation.
* Allergy to medications used in the study protocol.
* Presence of infection at the block site.
* Body mass index (BMI) \> 30.
* Preoperative or intraoperative conversion to general anesthesia.
* Pregnant patients.
* Severe spinal deformities preventing regional anesthesia application.
* Refusal to participate in the study.
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
1
State Entropy(SE)
Timeframe: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
2
Response Entropy(RE)
Timeframe: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Trial details
NCT IDNCT07272226
SponsorBursa Yuksek Ihtisas Training and Research Hospital