Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery (RACHYP)

Civil Hospices of Lyon

Status: Completed

Conditions: Hip Fractures

Treatments: Procedure: General anesthesia; Procedure: Unilateral spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03373864

69HCL17_0513

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Unilateral spinal anesthesia

Experimental group

Description:

In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort.

Treatment:

Procedure: Unilateral spinal anesthesia

General anesthesia

Active Comparator group

Description:

In this arm, the patients will have a general anesthesia.

Treatment:

Procedure: General anesthesia