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

NCT ID: NCT03373864

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-11

Study Completion Date

2019-11-25

Brief Summary

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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

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Conditions

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Hip Fractures

Keywords

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elderly AKI Unilateral spinal anesthesia general anesthesia hemodynamic stability MINS hip fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unilateral spinal anesthesia

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

Group Type EXPERIMENTAL

Unilateral spinal anesthesia

Intervention Type PROCEDURE

Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.

General anesthesia

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

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

General anesthesia following the latest recommendations for elderly patients (SFAR 2017)

Interventions

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Unilateral spinal anesthesia

Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.

Intervention Type PROCEDURE

General anesthesia

General anesthesia following the latest recommendations for elderly patients (SFAR 2017)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire DELSUC, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 36135347 (View on PubMed)

Other Identifiers

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69HCL17_0513

Identifier Type: -

Identifier Source: org_study_id