Indication for Surgery of the Posterior Segment Under Locoregional AnaesthesiaPhase 2CRAPONCT01963299
Clonidine - Ropivacaine in Peribulbar Anesthesia
A Phase 2 study testing 5 ml Ropivacaine 10% + physiological saline and 5 ml Ropivacaine 10% + Clonidine 1 µg/kg in people with Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia
- What is being tested?
- 5 ml Ropivacaine 10% + physiological saline and 5 ml Ropivacaine 10% + Clonidine 1 µg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2013to 7 Oct 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who have given written informed consent
- any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia
Who cannot join
- persons without National Health Insurance
- pregnant or breast-feeding women, patients < 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
- contra-indication for Loco-Regional Anesthesia
- hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
- disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
- uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP < 90 mmHg)
- Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
- Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery
This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.
The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.
The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.
- Being tested
- 5 ml Ropivacaine 10% + physiological saline, 5 ml Ropivacaine 10% + Clonidine 1 µg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 ml Ropivacaine 10% + physiological salineDrug
5 ml Ropivacaine 10% + Clonidine 1 µg/kgDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine alone group | Active comparator | Not described Receives: Drug: 5 ml Ropivacaine 10% + physiological saline |
| Ropivacaine/Clonidine group | Experimental | Not described Receives: Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia
Measured: up to 1 hour
Secondary outcomes (1)
Time to achieve akinesia
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study start16 Aug 2013
- Primary completion7 Oct 2013
- Study completion7 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indication for Surgery of the Posterior Segment Under Locoregional AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963299
- Sponsor's protocol ID
- GIRARD-BERTRAND 2013
- Acronym
- CRAPO
- Status last verified
- Jan 2019
- First submitted
- 10 Oct 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery
- ClinicalTrials.gov ID
- NCT01963299
- Acronym / sponsor ID
- CRAPO / GIRARD-BERTRAND 2013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Aug 2013 (actual)
- Primary completion
- 7 Oct 2013 (actual)
- Study completion
- 7 Oct 2013 (actual)
- First posted
- 16 Oct 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 study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.
The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.
The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine alone group | Active comparator | Drug: 5 ml Ropivacaine 10% + physiological saline |
| Ropivacaine/Clonidine group | Experimental | Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have given written informed consent
- any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia
Key exclusion criteria (8 listed)
- persons without National Health Insurance
- pregnant or breast-feeding women, patients < 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
- contra-indication for Loco-Regional Anesthesia
- hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
- disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
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 |
|---|---|---|
| 5 ml Ropivacaine 10% + physiological saline | Drug | Ropivacaine alone group |
| 5 ml Ropivacaine 10% + Clonidine 1 µg/kg | Drug | Ropivacaine/Clonidine group |
Primary outcome
Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia
Time frame: up to 1 hour
1 secondary outcome
Time to achieve akinesia
Time frame: up to 1 hour
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 10 Jan 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5 ml Ropivacaine 10% + physiological saline and 5 ml Ropivacaine 10% + Clonidine 1 µg/kg in people with Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia, run by Centre Hospitalier Universitaire Dijon 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 2 inclusion and 8 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 10 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2019.