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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Unilateral spinal anesthesia; Procedure: General anesthesia

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire DELSUC, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): November 25, 2019

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: elderly; general anesthesia; hip fracture; AKI; hemodynamic stability; MINS; Unilateral spinal anesthesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 69HCL17_0513

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No