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

Hip Fractures Clinical Trial

— RACHYP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373864
• Other study ID #: 69HCL17_0513
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: August 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Procedure:
• Unilateral spinal anesthesia
Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.
• General anesthesia
General anesthesia following the latest recommendations for elderly patients (SFAR 2017)

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality		30 days after surgery
Secondary	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
Secondary	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
Secondary	Hemoglobin rate	Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery	1 day after surgery
Secondary	Hemoglobin rate	Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery	3 days after surgery
Secondary	Blood loss	Intraoperative blood loss : quantity of blood in the suction container	At Day 0
Secondary	Quantity of ephedrine used during the intervention	Quantity of ephedrine used during operative time and recovery room	At Day 0
Secondary	Quantity of noradrenaline used during the intervention	Quantity of noradrenaline used during operative time and recovery room	At Day 0
Secondary	Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time		At Day 0
Secondary	Total time with MAP < 65 mmHg for more than 12 minutes during operative time		At Day 0
Secondary	Hospitalisation time		Up to 45 days after surgery
Secondary	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