Femoral Neck FracturePhase 4NCT01005550
Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
A Phase 4 study testing 6 mg of ropivacaine, 8 mg of ropivacaine and 10 mg of ropivacaine in people with Femoral Neck Fracture, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- 6 mg of ropivacaine, 8 mg of ropivacaine and 10 mg of ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Mar 2012
- Phase
- Phase 4
- 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
- older than 70
- dorsal decubitus surgery
- ASA score 1, 2, 3
- MMS score > or equal to 25
Who cannot join
- local anesthetic allergy
- spinal anaesthetic exclusion
- MMS score lower than 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study
This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.
- Conditions
- Femoral Neck Fracture
- Being tested
- 6 mg of ropivacaine, 8 mg of ropivacaine, 10 mg of ropivacaine, 12 mg of ropivacaine
- Keywords
- Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 mg of ropivacaineDrug
6 mg of ropivacaine are used for the spinal anaesthesia
8 mg of ropivacaineDrug
8 mg of ropivacaine are used for the spinal anaesthesia
10 mg of ropivacaineDrug
10 mg of ropivacaine for the spinal anaesthesia
12 mg of ropivacaineDrug
12 mg of ropivacaine for the spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| 6 mg of ropivacaine | Experimental | 6 mg of ropivacaine are used for the spinal anaesthesia Receives: Drug: 6 mg of ropivacaine |
| 8 mg of ropivacaine | Experimental | 8 mg of ropivacaine are used for the spinal anaesthesia Receives: Drug: 8 mg of ropivacaine |
| 10 mg of ropivacaine | Experimental | 10 mg of ropivacaine are used for the spinal anaesthesia Receives: Drug: 10 mg of ropivacaine |
| 12 mg of ropivacaine | Experimental | 12 mg of ropivacaine are used for the spinal anaesthesia Receives: Drug: 12 mg of ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
Measured: 1 hour (surgery intervention)
Secondary outcomes (4)
Spinal anaesthesia characteristics
Measured: 1 hour (surgery intervention)
Hemodynamics consequences
Measured: 1 hour (surgery intervention)
Patient and surgeon satisfaction
Measured: 1 hour (surgery intervention)
Morbidity and mortality
Measured: During 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionMar 2012
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 Femoral Neck FractureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal MEURET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005550
- Sponsor's protocol ID
- 2008.519
- Status last verified
- Dec 2010
- First submitted
- 14 Aug 2009
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.
PubMed 23592605
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study
- ClinicalTrials.gov ID
- NCT01005550
- Acronym / sponsor ID
- 2008.519
- Conditions
- Femoral Neck Fracture
- Keywords
- Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Nov 2009 (estimated)
- 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.
This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 6 mg of ropivacaine | Experimental | Drug: 6 mg of ropivacaine6 mg of ropivacaine are used for the spinal anaesthesia |
| 8 mg of ropivacaine | Experimental | Drug: 8 mg of ropivacaine8 mg of ropivacaine are used for the spinal anaesthesia |
| 10 mg of ropivacaine | Experimental | Drug: 10 mg of ropivacaine10 mg of ropivacaine are used for the spinal anaesthesia |
| 12 mg of ropivacaine | Experimental | Drug: 12 mg of ropivacaine12 mg of ropivacaine are used for the spinal anaesthesia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- older than 70
- dorsal decubitus surgery
- ASA score 1, 2, 3
- MMS score > or equal to 25
Key exclusion criteria (3 listed)
- local anesthetic allergy
- spinal anaesthetic exclusion
- MMS score lower than 25
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 |
|---|---|---|
| 6 mg of ropivacaine6 mg of ropivacaine are used for the spinal anaesthesia | Drug | 6 mg of ropivacaine |
| 8 mg of ropivacaine8 mg of ropivacaine are used for the spinal anaesthesia | Drug | 8 mg of ropivacaine |
| 10 mg of ropivacaine10 mg of ropivacaine for the spinal anaesthesia | Drug | 10 mg of ropivacaine |
| 12 mg of ropivacaine12 mg of ropivacaine for the spinal anaesthesia | Drug | 12 mg of ropivacaine |
Primary outcome
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
Time frame: 1 hour (surgery intervention)
4 secondary outcomes
Spinal anaesthesia characteristics
Time frame: 1 hour (surgery intervention)
Hemodynamics consequences
Time frame: 1 hour (surgery intervention)
Patient and surgeon satisfaction
Time frame: 1 hour (surgery intervention)
Morbidity and mortality
Time frame: During 3 days after surgery
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 28 May 2019.
- Results publication: PubMed 23592605Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.
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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.
Pascal MEURET, MD 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 Phase 4 study testing 6 mg of ropivacaine, 8 mg of ropivacaine and 10 mg of ropivacaine in people with Femoral Neck Fracture, 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 4 inclusion and 3 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 28 May 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery. (time frame: 1 hour (surgery intervention)). 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 NCT01005550, 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 28 May 2019.