Clinical trial NCT03373864: Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery
Official title: Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Unilateral spinal anesthesia
general anesthesia
hemodynamic stability
MINS
hip fracture
elderly
AKI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 154
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of episode of severe intraoperative hypotension
timeFrame: At Day 0
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days after surgery
measure: Myocardial injury after non cardiac surgery (MINS) occurence
timeFrame: 3 days after surgery
measure: Acute kidney injury (AKI) occurence
timeFrame: 3 days after surgery
measure: Hemoglobin rate
timeFrame: 1 day after surgery
measure: Hemoglobin rate
timeFrame: 3 days after surgery
measure: Blood loss
timeFrame: At Day 0
measure: Quantity of ephedrine used during the intervention
timeFrame: At Day 0
measure: Quantity of noradrenaline used during the intervention
timeFrame: At Day 0
measure: Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
timeFrame: At Day 0
measure: Total time with MAP < 65 mmHg for more than 12 minutes during operative time
timeFrame: At Day 0
measure: Hospitalisation time
timeFrame: Up to 45 days after surgery
measure: Number of episode of severe hypotension in the recovery room.
timeFrame: At Day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire DELSUC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simonin M, Delsuc C, Meuret P, Caruso L, Deleat-Besson R, Lamblin A, Huriaux L, Abraham P, Bidon C, Giai J, Riche B, Rimmele T. Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1262-1270. doi: 10.1213/ANE.0000000000006208. Epub 2022 Sep 22.