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

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Procedure: General anesthesia; Procedure: Unilateral spinal anesthesia

• Registration Number: NCT03373864
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-14
• Study Start: 2018-01-11
• Status Verified: 2019-08
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	General anesthesia	In this arm, the patients will have a general anesthesia.
Unilateral spinal anesthesia	Unilateral spinal anesthesia	In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort.

Primary Outcome Measures

Name	Time	Method
Number of episode of severe intraoperative hypotension	At Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalisation time	Up to 45 days after surgery
All-cause mortality	30 days after surgery
Myocardial injury after non cardiac surgery (MINS) occurence	3 days after surgery	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.
Quantity of ephedrine used during the intervention	At Day 0	Quantity of ephedrine used during operative time and recovery room
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
Acute kidney injury (AKI) occurence	3 days after surgery	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.)
Hemoglobin rate	3 days after surgery	Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Blood loss	At Day 0	Intraoperative blood loss : quantity of blood in the suction container
Quantity of noradrenaline used during the intervention	At Day 0	Quantity of noradrenaline used during operative time and recovery room
Number of episode of severe hypotension in the recovery room.	At Day 0	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.

Trial Locations

Locations (1)

Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation; 🇫🇷 Lyon, France