Hip FracturesRACHYPNCT03373864
Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia for the Hip Fracture Surgery
A study testing Unilateral spinal anesthesia and General anesthesia in people with Hip Fractures, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Unilateral spinal anesthesia and General anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2018to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.
Who cannot join
- 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®).
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation
Lyon, 69003
About this study
Official title: 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.
- Conditions
- Hip Fractures
- Being tested
- Unilateral spinal anesthesia, General anesthesia
- Keywords
- Unilateral spinal anesthesia, general anesthesia, hemodynamic stability, MINS, hip fracture, elderly, AKI
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral spinal anesthesiaProcedure or surgery
Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.
General anesthesiaProcedure or surgery
General anesthesia following the latest recommendations for elderly patients (SFAR 2017)
| Study group | Role | What they receive |
|---|---|---|
| Unilateral spinal anesthesia | Experimental | In this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort. Receives: Procedure: Unilateral spinal anesthesia |
| General anesthesia | Active comparator | In this arm, the patients will have a general anesthesia. Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Day 0
Secondary outcomes (12)
All-cause mortality
Measured: 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.
Measured: 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.)
Measured: 3 days after surgery
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Measured: 1 day after surgery
Hemoglobin rate
Mean decrease between preoperative and postoperative values at 1st and 3rd day after surgery
Measured: 3 days after surgery
Blood loss
Intraoperative blood loss : quantity of blood in the suction container
Measured: At Day 0
Quantity of ephedrine used during the intervention
Quantity of ephedrine used during operative time and recovery room
Measured: At Day 0
Quantity of noradrenaline used during the intervention
Quantity of noradrenaline used during operative time and recovery room
Measured: At Day 0
Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
Measured: At Day 0
Total time with MAP < 65 mmHg for more than 12 minutes during operative time
Measured: At Day 0
Hospitalisation time
Measured: 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.
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start11 Jan 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire DELSUC, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373864
- Sponsor's protocol ID
- 69HCL17_0513
- Acronym
- RACHYP
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36135347
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.
- ClinicalTrials.gov ID
- NCT03373864
- Acronym / sponsor ID
- RACHYP / 69HCL17_0513
- Conditions
- Hip Fractures
- Keywords
- Unilateral spinal anesthesia, general anesthesia, hemodynamic stability, MINS, hip fracture, elderly, AKI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral spinal anesthesia | Experimental | Procedure: Unilateral spinal anesthesiaIn this arm, the patients will have a hypobaric lateral spinal anesthesia. Sedation can be added for the patients comfort. |
| General anesthesia | Active comparator | Procedure: General anesthesiaIn this arm, the patients will have a general anesthesia. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Every patient aged 70 years or more who undergoes urgent surgery for a traumatic hip fracture.
Key exclusion criteria (12 listed)
- 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®)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral spinal anesthesiaUnilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb. | Procedure or surgery | Unilateral spinal anesthesia |
| General anesthesiaGeneral anesthesia following the latest recommendations for elderly patients (SFAR 2017) | Procedure or surgery | General anesthesia |
Primary outcome
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.
12 secondary outcomes
All-cause mortality
Time frame: 30 days after surgery
Myocardial injury after non cardiac surgery (MINS) occurence
Time frame: 3 days after surgery
Acute kidney injury (AKI) occurence
Time frame: 3 days after surgery
Hemoglobin rate
Time frame: 1 day after surgery
Hemoglobin rate
Time frame: 3 days after surgery
Blood loss
Time frame: At Day 0
Quantity of ephedrine used during the intervention
Time frame: At Day 0
Quantity of noradrenaline used during the intervention
Time frame: At Day 0
Number of episodes with a MAP < 65 mmHg for more than 12 minutes during operative time
Time frame: At Day 0
Total time with MAP < 65 mmHg for more than 12 minutes during operative time
Time frame: At Day 0
Hospitalisation time
Time frame: Up to 45 days after surgery
Number of episode of severe hypotension in the recovery room.
Time frame: At Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 36135347Simonin 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.
Related trials for Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Active, not recruitingPhase 2
BDSF Vs DHS With Anterotational Screw in Vertical FNF
Evaluation of BDSF in FNF
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire DELSUC, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral spinal anesthesia and General anesthesia in people with Hip Fractures, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episode of severe intraoperative hypotension (time frame: At Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.