Postoperative PainPhase 4NAROSYDNCT02449486
Ropivacaine After Sternotomy
A Phase 4 study testing Ropivacaine in people with Postoperative Pain, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2014to Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABG or heart valve surgery patients
Who cannot join
- Psychic disorders
- Sleep apnea syndrome
- Diabetes mellitus (insulin dependent)
- Obesity, body mass index (BMI) ≥ 35
- Cardiac insufficiency, ejection fraction (EF) ≤ 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery
Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.
Read the detailed description
A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine
- Keywords
- Requirement of postoperative pain medication
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Ropivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours Receives: Drug: Ropivacaine |
| Placebo | Placebo comparator | Saline infusion 4 ml/h for 48 hours Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative oxycodone consumption
postoperative PCA administered oxycodone
Measured: 48 postoperative hours
Secondary outcomes (1)
Pain measured with Visual Analog Scale
pain measured with VAS at rest and on movement
Measured: 48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pasi K Lahtinen, MD, PhD, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449486
- Sponsor's protocol ID
- 5070221
- Acronym
- NAROSYD
- Status last verified
- Apr 2018
- First submitted
- 18 May 2015
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published in a peer reviewed medical publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine Infusion to Alleviate Postoperative Pain After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02449486
- Acronym / sponsor ID
- NAROSYD / 5070221
- Conditions
- Postoperative Pain
- Keywords
- Requirement of postoperative pain medication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 May 2015 (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.
Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting (CABG) or heart valve surgery to diminish postoperative pain.
Detailed description
A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU. All patients receive a standardized anesthesia during surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine 4 ml/h (8 mg/h) continuous infusion for 48 hours |
| Placebo | Placebo comparator | Drug: RopivacaineSaline infusion 4 ml/h for 48 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABG or heart valve surgery patients
Key exclusion criteria (5 listed)
- Psychic disorders
- Sleep apnea syndrome
- Diabetes mellitus (insulin dependent)
- Obesity, body mass index (BMI) ≥ 35
- Cardiac insufficiency, ejection fraction (EF) ≤ 30
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 | Drug | Placebo, Ropivacaine |
Primary outcome
Postoperative oxycodone consumption
Time frame: 48 postoperative hours
postoperative PCA administered oxycodone
1 secondary outcome
Pain measured with Visual Analog Scale
Time frame: 48 postoperative hours
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 24 Apr 2018.
- Individual participant dataSharing planned: No. Data will be published in a peer reviewed medical publication
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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.
Pasi K Lahtinen, MD, PhD study director
Kuopio University Hospital
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 people with Postoperative Pain, run by Kuopio University Hospital at 1 site in Finland.
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 5 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 24 Apr 2018. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
Postoperative oxycodone consumption (time frame: 48 postoperative hours). 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 24 Apr 2018.