Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.

Conditions
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Hip Fractures

Intervention / Treatment
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* Procedure: Unilateral spinal anesthesia
* Procedure: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unilateral spinal anesthesia<br>In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort. | Procedure: Unilateral spinal anesthesia<br>* Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.<br>|
| Active Comparator: General anesthesia<br>In this arm, the patients will have a general anesthesia. | Procedure: General anesthesia<br>* General anesthesia following the latest recommendations for elderly patients (SFAR 2017)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episode of severe intraoperative hypotension | Occurrence of an episode of severe hypotension defined as a mean arterial pressure (MAP) < 65 mmHg for more than 12 minutes during the operative time. | At Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days after surgery | 
| Myocardial injury after non cardiac surgery (MINS) occurence | Elevated troponin T level (troponin T > 100 ng/L) in aged patients (over 75 years) and for patients under the age of 75 years old Troponin T> 34 ng/L for men and troponin T > 16 ng / L for women, in a blood test performed in the first 3 days after surgery due to a myocardial ischemia. | 3 days after surgery | 
| Acute kidney injury (AKI) occurence | Postoperative AKI is defined as an increase in serum creatinine between preoperative and postoperative values (increase of more than 1.5-fold or more than 0.3mg/dL of the value before surgery.) | 3 days after surgery | 
| Hemoglobin rate | Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery | 1 day after surgery | 
| Hemoglobin rate | Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery | 3 days after surgery | 
| Blood loss | Intraoperative blood loss : quantity of blood in the suction container | At Day 0 | 
| Quantity of ephedrine used during the intervention | Quantity of ephedrine used during operative time and recovery room | At Day 0 | 
| Quantity of noradrenaline used during the intervention | Quantity of noradrenaline used during operative time and recovery room | At Day 0 | 
| Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time |  | At Day 0 | 
| Total time with MAP < 65 mmHg for more than 12 minutes during operative time |  | At Day 0 | 
| Hospitalisation time |  | Up to 45 days after surgery | 
| Number of episode of severe hypotension in the recovery room. | Occurrence of an episode of severe hypotension defined as a mean arterial pressure (MAP) < 65 mmHg for more than 12 minutes in the recovery room. | At Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral spinal anesthesia, general anesthesia, hemodynamic stability, MINS, hip fracture, elderly, AKI