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

NCT03373864 | Completed

• 1 other identifier: 69HCL17_0513
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• All-cause mortality

  30 days after surgery

• Myocardial injury after non cardiac surgery (MINS) occurence

  3 days after surgery

• Acute kidney injury (AKI) occurence

  3 days after surgery

• Hemoglobin rate

  1 day after surgery

• Hemoglobin rate

  3 days after surgery

Study Arms (2)

Unilateral spinal anesthesia

EXPERIMENTAL

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

Procedure: Unilateral spinal anesthesia

General anesthesia

ACTIVE COMPARATOR

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

Procedure: General anesthesia

Interventions

Unilateral spinal anesthesia PROCEDURE

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

Unilateral spinal anesthesia

General anesthesia PROCEDURE

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

General anesthesia

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation

Lyon, 69003, France

Location

Related Publications (1)

• 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.

  PMID: 36135347 RESULT

MeSH Terms

Conditions

Hip Fractures

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Claire DELSUC, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 14, 2017
• Study Start: January 11, 2018
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)