Patients Undergoing Lower Limb SurgeryPhase 4ROPI-LEVONCT01935596
Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
A Phase 4 study testing ropivacaïne and lévobupivacaïne in people with Patients Undergoing Lower Limb Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients Undergoing Lower Limb Surgery
- What is being tested?
- ropivacaïne and lévobupivacaïne
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Apr 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient admitted to the emergency for lower limb trauma,
- age over 18 years and below 65 years
- lower limb trauma surgery can be performed under spinal anesthesia.
Who cannot join
- Refusal of patients to participate in the study,
- Patient with cons-indication to spinal anesthesia:
- Local anesthetic allergy agents (1/13000)
- bleeding disorders, including pharmacological origin
- infection at the puncture site,
- refusal of spinal anesthesia by the patient,
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- Patient trust,
- Patients whose coagulation is abnormal.
- Patients with cognitive impairment or incapacitated adult,
- Multiple trauma,
- Porphyria,
- Central preexisting neuropathy,
- A history of spinal surgery,
- Epilepsy uncontrolled by treatment,
- Hypovolemia,
- Pregnant or lactating women,
- Participation in another ongoing clinical trial,
- Patient on anticoagulant therapy,
- Patient not affiliated with a social security system.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.
Read the detailed description
Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.
Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.
- Conditions
- Patients Undergoing Lower Limb Surgery
- Being tested
- ropivacaïne, lévobupivacaïne
- Keywords
- Anesthesia, Randomized study, Lower limbs surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaïneDrug
spinal anesthesia.
lévobupivacaïneDrug
| Study group | Role | What they receive |
|---|---|---|
| ropivacaïne 0,5%, | Active comparator | intrathecal administration of 15mg of ropivacaine 0.5%. Receives: Drug: ropivacaïne |
| lévobupivacaïne 0,5% | Active comparator | intrathecal administration of 15mg of levobupivacaine 0.5% Receives: Drug: lévobupivacaïne |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of anesthesia on sensitivity
Thermo-algesic exploration of sensitivity through the application of an ice cube
Measured: during 6h after induction
Secondary outcomes (1)
Duration of anesthesia on motor block
Measured: during 6h after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
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 Patients Undergoing Lower Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé DUPONT, Professor, Study director, CHU Amiens France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935596
- Sponsor's protocol ID
- PI09-PR-DUPONT
- Acronym
- ROPI-LEVO
- Status last verified
- Nov 2025
- First submitted
- 23 Aug 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
https://www.em-consulte.com/article/998410/comparaison-de-l-efficacite-de-la-levobupivacaine-
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%
- ClinicalTrials.gov ID
- NCT01935596
- Acronym / sponsor ID
- ROPI-LEVO / PI09-PR-DUPONT
- Conditions
- Patients Undergoing Lower Limb Surgery
- Keywords
- Anesthesia, Randomized study, Lower limbs surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Sep 2013 (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 Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.
Detailed description
Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.
Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaïne 0,5%, | Active comparator | Drug: ropivacaïneintrathecal administration of 15mg of ropivacaine 0.5%. |
| lévobupivacaïne 0,5% | Active comparator | Drug: lévobupivacaïneintrathecal administration of 15mg of levobupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient admitted to the emergency for lower limb trauma,
- age over 18 years and below 65 years
- lower limb trauma surgery can be performed under spinal anesthesia.
Key exclusion criteria (19 listed)
- Refusal of patients to participate in the study,
- Patient with cons-indication to spinal anesthesia:
- Patient trust,
- Patients whose coagulation is abnormal.
- Patients with cognitive impairment or incapacitated adult,
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 |
|---|---|---|
| ropivacaïnespinal anesthesia. | Drug | ropivacaïne 0,5%, |
| lévobupivacaïne | Drug | lévobupivacaïne 0,5% |
Primary outcome
duration of anesthesia on sensitivity
Time frame: during 6h after induction
Thermo-algesic exploration of sensitivity through the application of an ice cube
1 secondary outcome
Duration of anesthesia on motor block
Time frame: during 6h after induction
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 Nov 2025.
- Results publicationhttps://www.em-consulte.com/article/998410/comparaison-de-l-efficacite-de-la-levobupivacaine-
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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.
Hervé DUPONT, Professor study director
CHU Amiens France
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 ropivacaïne and lévobupivacaïne in people with Patients Undergoing Lower Limb Surgery, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 19 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 Nov 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.
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?
duration of anesthesia on sensitivity (time frame: during 6h after induction). 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 NCT01935596, 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 Nov 2025.