Cardiac SurgeryPhase 4NCT01196767
Ropivacaine Though Laterosternal Catheters After Cardiac Surgery
A Phase 4 study testing Ropivacaine (in one arm); catheterization (in both). in people with Cardiac Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Ropivacaine (in one arm); catheterization (in both).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Nov 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled cardiac surgery.
Who cannot join
- - surgery in emergency
- thoracotomy
- cardiac graft
- redo
- pregnancy
- patient's refusal
Show all 15Show fewer
- minor or adult under legal protection
- psychiatric ongoing disease
- addiction to opiates
- ongoing opiate treatment
- inability to use a PCA device
- respiratory insuffiency (Vital capacity or maximal expired volume per sec. < 50% of the expected value, or mean PAP > 50 mmHg)
- intra-aortic balloon
- severe renal insuffiency
- history of allergy or intolerance to: morphine, acetaminophen, bupivacaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters
This is a prospective double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.
Read the detailed description
Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.
- Conditions
- Cardiac Surgery
- Being tested
- Ropivacaine (in one arm); catheterization (in both).
- Keywords
- Sternotomy, Pain, Respiratory function, Opiates, Patient-controlled, Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
- Medical subject headings
- Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine (in one arm); catheterization (in both).Drug
Parallel study with two groups:
- ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
- same protocol, with normal saline instead of ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | Not described Receives: Drug: Ropivacaine (in one arm); catheterization (in both). |
| normal saline | Other | Not described Receives: Drug: Ropivacaine (in one arm); catheterization (in both). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
Measured: every 4 hours during 48 hours
Secondary outcomes (9)
Morphine consumption on PCA device
Measured: every 4 hours during 48 hours
Pain score at rest, expressed on a visual analogue scale.
Measured: every 4 hours during 48 hours
Vital capacity and inspiratory reserve volume, related to the preoperative values
Measured: daily during 48 hours
Postoperative blood level of troponin
Measured: every 8 hours during 48 hours
Arterial blood gases
Measured: every 4 hours during 48 hours
Time to first flatus
Measured: daily during 48 hours
Number of participants with adverse events
nausea and vomiting, pruritus
Measured: daily during 48 hours
Postoperative blood level of ropivacaine at day + 1 and day + 2
Measured: daily during 48 hours
Signs of intoxication to ropivacaine
Measured: eventual reports
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionNov 2010
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 Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vedat Eldjezi, MB, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196767
- Sponsor's protocol ID
- CHU-0080
- Status last verified
- Apr 2013
- First submitted
- 26 Jul 2010
- Last updated
- 4 Apr 2013
- Results posted
- No
Publications
Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f.
PubMed 22266899
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Cardiac Surgery: Effects of a Continuous Infusion of Ropivacaine Through Laterosternal Catheters
- ClinicalTrials.gov ID
- NCT01196767
- Acronym / sponsor ID
- CHU-0080
- Conditions
- Cardiac Surgery
- Keywords
- Sternotomy, Pain, Respiratory function, Opiates, Patient-controlled, Scheduled cardiac surgery under general anaesthesia without any locoregional anaesthesia protocol other than this presently studied
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Sep 2010 (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 double-blinded and randomised study involving patients undergoing cardiac surgery with median sternotomy, the effects on postoperative analgesia of a 48-hr continuous infusion of ropivacaine 2 mg.mL-1, at the rate of 4 mL.hr-1 through two catheters inserted at the lateral edges of the sternum will be studied, versus a control group in which normal saline will be infused in the same conditions.
Detailed description
Diverse methods for infusion of local anaesthetics after cardiac surgery have been proposed, but none of them provided high-level evidence of efficacy. The catheters studied here are designed for a surgical insertion before closure of the sternotomy, with the aim of infusing the drug the closest possible of the terminations of intercostal nerves.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Drug: Ropivacaine (in one arm); catheterization (in both). |
| normal saline | Other | Drug: Ropivacaine (in one arm); catheterization (in both). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled cardiac surgery.
Key exclusion criteria (15 listed)
- - surgery in emergency
- thoracotomy
- cardiac graft
- redo
- pregnancy
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 |
|---|---|---|
| Ropivacaine (in one arm); catheterization (in both).Parallel study with two groups: 1. ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump. 2. same protocol, with normal saline instead of ropivacaine. | Drug | normal saline, ropivacaine |
Primary outcome
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale.
Time frame: every 4 hours during 48 hours
9 secondary outcomes
Morphine consumption on PCA device
Time frame: every 4 hours during 48 hours
Pain score at rest, expressed on a visual analogue scale.
Time frame: every 4 hours during 48 hours
Vital capacity and inspiratory reserve volume, related to the preoperative values
Time frame: daily during 48 hours
Postoperative blood level of troponin
Time frame: every 8 hours during 48 hours
Arterial blood gases
Time frame: every 4 hours during 48 hours
Time to first flatus
Time frame: daily during 48 hours
Number of participants with adverse events
Time frame: daily during 48 hours
Postoperative blood level of ropivacaine at day + 1 and day + 2
Time frame: daily during 48 hours
Signs of intoxication to ropivacaine
Time frame: eventual reports
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 4 Apr 2013.
- Results publication: PubMed 22266899Eljezi V, Duale C, Azarnoush K, Skrzypczak Y, Sautou V, Pereira B, Tsokanis I, Schoeffler P. The analgesic effects of a bilateral sternal infusion of ropivacaine after cardiac surgery. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):166-74. doi: 10.1097/AAP.0b013e318240957f.
- Related InfoLink provided by the sponsor.
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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.
Vedat Eldjezi, MB principal investigator
University Hospital, Clermont-Ferrand
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 Ropivacaine (in one arm); catheterization (in both). in people with Cardiac Surgery, run by University Hospital, Clermont-Ferrand 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 15 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 4 Apr 2013. 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?
Pain score at mobilization (lying position for measurement of central venous pressure), expressed on a visual analogue scale. (time frame: every 4 hours during 48 hours). 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 NCT01196767, 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 4 Apr 2013.