Cardiac SurgeryPhase 2/3NCT00586976
A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
A Phase 2/3 study testing Ropivacaine and Normal saline in people with Cardiac Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Ropivacaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2008
- Phase
- Phase 2/3
- 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
- Be greater than 18 years of age
- Be undergoing a cardiac surgical procedure via median sternotomy (i.e., exclude the occasional thoracotomy, since much greater pain with that surgical approach post-operatively)
Who cannot join
- Are unable to grant informed consent or comply with study procedure
- Are undergoing emergency open heart-surgery
- Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
- Age < 18 years of age (children have dosing and toxicity concerns)
- Are pregnant (pregnancy changes pain thresholds)
- Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)
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- Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)
- Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)
- Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
About this study
Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
Read the detailed description
Background:
Cardiac surgery is associated with pain in the post-operative period. Recently the ability to infuse local anesthetic drugs into the area of the sternal wound has become available. The studies that have been done thus far have shown efficacy in controlling pain but have been too small to show clinically significant patient outcome differences.
Specific Aim:
We plan to conduct a phase II/III study of local anesthetic infusion into the sternal wound in adult patients undergoing cardiac surgery.
In the Phase II study, 40 patients will be enrolled in a prospective observational open label, dose escalation study of safety and efficacy of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores and opioid consumption. Outcome measures for safety will be plasma ropivacaine concentrations and adverse events.
The dose determined in the phase II study will be used in the Phase III study. In this study, 200 patients will be enrolled in a double blind prospective, randomized, double blind; placebo controlled trial of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores, opioid consumption, time to extubation, pulmonary function tests, duration of ICU and hospital stay, all cause morbidity and mortality. Outcome measure for safety will be adverse events.
Hypothesis:
Local anesthetic infusion into the sternal wound will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
Significance:
This will be the first large randomized controlled clinical trial assessing outcomes with the use of local anesthetic infusion into the sternal wound in patients undergoing open-heart surgery.
- Conditions
- Cardiac Surgery
- Being tested
- Ropivacaine, Normal saline
- Keywords
- pain, ropivacaine, infusion, sternotomy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
0.3% ropivacaine infusion at 4 ml/hr for 64 hours.
Normal salineDrug
Normal saline infusion at 4 ml/hour for 64 hours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ropivicaine infusion into the sternal wound Receives: Drug: Ropivacaine |
| 2 | Placebo comparator | Normal saline infusion into the sternal wound Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain
Measured: 64 hours
Secondary outcomes (3)
drug toxicity
Measured: 64 hours
infection
Measured: 64 hours
narcotic usage
Measured: 64 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionJun 2007
- Study completionJun 2008
Why it stopped: Stopped by DSMB due to increased wound infection rate.
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 Mayo ClinicThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Investigators
- Gregory A. Nuttall, M.D., Principal investigator, Mayo Clinic College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586976
- Sponsor's protocol ID
- 1107-05
- Other IDs
- Contract number 1a5777
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2007
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agarwal S, Nuttall GA, Johnson ME, Hanson AC, Oliver WC Jr. A prospective, randomized, blinded study of continuous ropivacaine infusion in the median sternotomy incision following cardiac surgery. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):145-50. doi: 10.1097/AAP.0b013e318281a348.
PubMed 23386053
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00586976
- Acronym / sponsor ID
- 1107-05
- Conditions
- Cardiac Surgery
- Keywords
- pain, ropivacaine, infusion, sternotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped by DSMB due to increased wound infection rate.
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- Jul 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Jan 2008 (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.
Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
Detailed description
Background:
Cardiac surgery is associated with pain in the post-operative period. Recently the ability to infuse local anesthetic drugs into the area of the sternal wound has become available. The studies that have been done thus far have shown efficacy in controlling pain but have been too small to show clinically significant patient outcome differences.
Specific Aim:
We plan to conduct a phase II/III study of local anesthetic infusion into the sternal wound in adult patients undergoing cardiac surgery.
In the Phase II study, 40 patients will be enrolled in a prospective observational open label, dose escalation study of safety and efficacy of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores and opioid consumption. Outcome measures for safety will be plasma ropivacaine concentrations and adverse events.
The dose determined in the phase II study will be used in the Phase III study. In this study, 200 patients will be enrolled in a double blind prospective, randomized, double blind; placebo controlled trial of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores, opioid consumption, time to extubation, pulmonary function tests, duration of ICU and hospital stay, all cause morbidity and mortality. Outcome measure for safety will be adverse events.
Hypothesis:
Local anesthetic infusion into the sternal wound will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
Significance:
This will be the first large randomized controlled clinical trial assessing outcomes with the use of local anesthetic infusion into the sternal wound in patients undergoing open-heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RopivacaineRopivicaine infusion into the sternal wound |
| 2 | Placebo comparator | Drug: Normal salineNormal saline infusion into the sternal wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be greater than 18 years of age
- Be undergoing a cardiac surgical procedure via median sternotomy (i.e., exclude the occasional thoracotomy, since much greater pain with that surgical approach post-operatively)
Key exclusion criteria (9 listed)
- Are unable to grant informed consent or comply with study procedure
- Are undergoing emergency open heart-surgery
- Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
- Age < 18 years of age (children have dosing and toxicity concerns)
- Are pregnant (pregnancy changes pain thresholds)
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 |
|---|---|---|
| Ropivacaine0.3% ropivacaine infusion at 4 ml/hr for 64 hours. | Drug | 1 |
| Normal salineNormal saline infusion at 4 ml/hour for 64 hours. | Drug | 2 |
Primary outcome
Visual analog pain
Time frame: 64 hours
3 secondary outcomes
drug toxicity
Time frame: 64 hours
infection
Time frame: 64 hours
narcotic usage
Time frame: 64 hours
Results and safety
The study was stopped early (reason given: Stopped by DSMB due to increased wound infection rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 23386053Agarwal S, Nuttall GA, Johnson ME, Hanson AC, Oliver WC Jr. A prospective, randomized, blinded study of continuous ropivacaine infusion in the median sternotomy incision following cardiac surgery. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):145-50. doi: 10.1097/AAP.0b013e318281a348.
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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.
Gregory A. Nuttall, M.D. principal investigator
Mayo Clinic College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine and Normal saline in people with Cardiac Surgery, run by Mayo Clinic at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 7 Apr 2015. 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 United States. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Stopped by DSMB due to increased wound infection rate.). Results are not available in the source record.
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?
Visual analog pain (time frame: 64 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 NCT00586976, 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 7 Apr 2015.