Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Ris… (NCT07597148) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
70 participantsStarted 2026-06-01
Plain-language summary
Spinal anesthesia is a common and preferred anesthetic technique for lower extremity orthopedic surgery in elderly patients. However, it can cause a significant drop in blood pressure (hypotension), especially in high-risk older patients with multiple medical conditions. This complication can lead to serious consequences such as heart attack, stroke, or death in vulnerable patients.
This study investigates whether keeping patients in a lateral (side-lying) position for 15 minutes after spinal anesthesia - instead of immediately turning them onto their back (supine position) - can reduce the risk of hypotension. When a patient lies on their side after receiving spinal anesthesia with a heavy (hyperbaric) local anesthetic, the medication tends to stay concentrated on the lower (operative) side, resulting in a more limited nerve block. This may help preserve blood pressure stability.
We will enroll 70 patients aged 65 years or older with high anesthetic risk (ASA physical status III or IV) scheduled for unilateral lower extremity orthopedic surgery under spinal anesthesia. Patients will be randomly assigned to two groups: one group will be kept in the lateral decubitus position (operative side down) for 15 minutes before being turned supine, and the other group will be turned supine immediately after spinal anesthesia. Blood pressure, heart rate, and oxygen saturation will be monitored continuously. The primary outcome is the incidence of hypotension during the first 15 minutes after spinal anesthesia.
Who can participate
Age range
65 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 65 years or older
* ASA physical status classification III or IV
* Scheduled for unilateral lower extremity orthopedic surgery (hip fracture, femur fracture, knee arthroplasty, tibia-fibula fracture, or similar procedures)
* Eligible for spinal anesthesia
* Written informed consent obtained
Exclusion Criteria:
* Contraindications to spinal anesthesia (coagulopathy, recent anticoagulant or antiplatelet use without adequate washout period, local infection at injection site)
* Severe neurological disease or pre-existing motor or sensory deficit
* Significant spinal deformity (severe scoliosis, kyphosis) or history of previous spinal surgery
* Known allergy to local anesthetics
* Decompensated heart failure (ejection fraction below 30%)
* Uncontrolled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
* Emergency surgery
* Severe hypovolemia or active bleeding
* Advanced dementia or inability to communicate
* Body mass index above 40 kg/m²
* Refusal to participate
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
Incidence of Hypotension
Timeframe: From spinal anesthesia to 15 minutes after administration
Trial details
NCT IDNCT07597148
SponsorUniversity of Health Sciences Balikesir Hospital Eduation and Research