Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery (NCT03373864) | Clinical Trial Compass
CompletedNot Applicable
Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery
France154 participantsStarted 2018-01-11
Plain-language summary
Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability.
Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects.
The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.
Who can participate
Age range
70 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:
\- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.
Exclusion Criteria:
* Patients younger than 70 years of age
* Pathological fractures or multiple trauma
* Contraindications to spinal anesthesia:
* allergy to the local anesthetic
* patients treated by clopidogrel (Plavix®)
* patients treated by oral anticoagulants: dabigatran (Pradaxa®), rivaroxaban (Xarelto®), or apixaban (Eliquis®).
* Coagulation disorders: (Prothrombin Time \< 50 %, or Partial Thromboplastin Time ratio \> 1.5, or platelets \< 80 G/L),
* Local infection of the puncture site
* hyperthermia (\> 38.5°C)
* agitated patients
* patients included in another study
* patients under judicial protection
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
Number of episode of severe intraoperative hypotension