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NCT Number: NCT03373864

Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the 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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral spinal anesthesia

Procedure

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

General Anesthesia

Procedure

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

Primary outcomes

  1. Number of episode of severe intraoperative hypotension

    Time frame: At Day 0

    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 outcomes

  1. All-cause mortality

    Time frame: 30 days after surgery

  2. Myocardial injury after non cardiac surgery (MINS) occurence

    Time frame: 3 days after surgery

    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. Acute kidney injury (AKI) occurence

    Time frame: 3 days after surgery

    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.)

  4. Hemoglobin rate

    Time frame: 1 day after surgery

    Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery

  5. Hemoglobin rate

    Time frame: 3 days after surgery

    Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery

  6. Blood loss

    Time frame: At Day 0

    Intraoperative blood loss : quantity of blood in the suction container

  7. Quantity of ephedrine used during the intervention

    Time frame: At Day 0

    Quantity of ephedrine used during operative time and recovery room

  8. Quantity of noradrenaline used during the intervention

    Time frame: At Day 0

    Quantity of noradrenaline used during operative time and recovery room

  9. Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time

    Time frame: At Day 0

  10. Total time with MAP < 65 mmHg for more than 12 minutes during operative time

    Time frame: At Day 0

  11. Hospitalisation time

    Time frame: Up to 45 days after surgery

  12. Number of episode of severe hypotension in the recovery room.

    Time frame: At Day 0

    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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RACHYP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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