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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unilateral spinal anesthesia
General anesthesia
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Unilateral spinal anesthesia, general anesthesia, hemodynamic stability, MINS, hip fracture, elderly, AKI

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Unilateral spinal anesthesia

General anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-cause mortality
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.
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.)
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Blood loss
Intraoperative blood loss : quantity of blood in the suction container
Quantity of ephedrine used during the intervention
Quantity of ephedrine used during operative time and recovery room
Quantity of noradrenaline used during the intervention
Quantity of noradrenaline used during operative time and recovery room
Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
Total time with MAP < 65 mmHg for more than 12 minutes during operative time
Hospitalisation time
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.

Full Information

First Posted
December 7, 2017
Last Updated
May 19, 2020
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03373864
Brief Title
Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery
Acronym
RACHYP
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Unilateral spinal anesthesia, general anesthesia, hemodynamic stability, MINS, hip fracture, elderly, AKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral spinal anesthesia
Arm Type
Experimental
Arm Description
In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort.
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
In this arm, the patients will have a general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Unilateral spinal anesthesia
Intervention Description
Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Intervention Description
General anesthesia following the latest recommendations for elderly patients (SFAR 2017)
Primary Outcome Measure Information:
Title
Number of episode of severe intraoperative hypotension
Description
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.
Time Frame
At Day 0
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days after surgery
Title
Myocardial injury after non cardiac surgery (MINS) occurence
Description
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.
Time Frame
3 days after surgery
Title
Acute kidney injury (AKI) occurence
Description
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.)
Time Frame
3 days after surgery
Title
Hemoglobin rate
Description
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Time Frame
1 day after surgery
Title
Hemoglobin rate
Description
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Time Frame
3 days after surgery
Title
Blood loss
Description
Intraoperative blood loss : quantity of blood in the suction container
Time Frame
At Day 0
Title
Quantity of ephedrine used during the intervention
Description
Quantity of ephedrine used during operative time and recovery room
Time Frame
At Day 0
Title
Quantity of noradrenaline used during the intervention
Description
Quantity of noradrenaline used during operative time and recovery room
Time Frame
At Day 0
Title
Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
Time Frame
At Day 0
Title
Total time with MAP < 65 mmHg for more than 12 minutes during operative time
Time Frame
At Day 0
Title
Hospitalisation time
Time Frame
Up to 45 days after surgery
Title
Number of episode of severe hypotension in the recovery room.
Description
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.
Time Frame
At Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire DELSUC, MD, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
36135347
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.
Results Reference
derived

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

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