Minimal Invasive Cardiac SurgeryNCT05648266
Serratus Plane Block After Minimally Invasive Mitral Valve Repair
A study testing Continous SAPB (Ropivacain) in people with Minimal Invasive Cardiac Surgery and Minimal Invasive Cardiac Surgery Mitral Valve Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups. The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Minimal Invasive Cardiac Surgery, Minimal Invasive Cardiac Surgery Mitral Valve Surgery, Serratus Anterior Plane Block
- What is being tested?
- Continous SAPB (Ropivacain)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2022to 1 Jul 2024
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Planned minimal invasive mitral valve repair via right anterior thoracotomy
Who cannot join
- Pregenancy
- Opioid abuse
- Historyof chronic pain
- Allergy to local anaesthetics (in this case ropivacain)
- Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
About this study
Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.
The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.
The control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.
- Conditions
- Minimal Invasive Cardiac Surgery, Minimal Invasive Cardiac Surgery Mitral Valve Surgery, Serratus Anterior Plane Block
- Being tested
- Continous SAPB (Ropivacain), institutional standard of care pain medication protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous SAPB (Ropivacain)Drug
postoperative SAPB and pain catheter with continous administered (5ml/h Ropivacain 0,2%) for 48h
institutional standard of care pain medication protocolOther
institutional standard of care pain medication protocol
| Study group | Role | What they receive |
|---|---|---|
| Continuous SAPB | Active comparator | postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h) Receives: Drug: Continous SAPB (Ropivacain); Other: institutional standard of care pain medication protocol |
| Placebo | Placebo comparator | standard of care Receives: Other: institutional standard of care pain medication protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Numeric Rating Scale after MIC-MKR
Numeric Rating Scale (0-10, 0=smallest value, 10=greatest value)
Measured: within 12, 24 and 48 hours after surgery
Secondary outcomes (1)
Difference of opioid consumption after MIC-MVR
daily, cumulative dose of opioid analgetic medication after MIC-MKR
Measured: within 12, 24 and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Apr 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Invasive Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648266
- Sponsor's protocol ID
- 19518181202119
- Status last verified
- Sep 2025
- First submitted
- 5 Dec 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Plane Block After Minimally Invasive Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT05648266
- Acronym / sponsor ID
- 19518181202119
- Conditions
- Minimal Invasive Cardiac Surgery, Minimal Invasive Cardiac Surgery Mitral Valve Surgery, Serratus Anterior Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Dec 2022 (actual)
- 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.
Patients undergoing minimally invasive mitral valve reconstruction via small thoracotomy are randomized into two groups.
The intervention group receives serratus anterior plane block after minimally invasive mitral-valve reconstruction, following 48h infusion with ropivacaine 2% continually.
The control group receives a placebo pump without infusion. Primary endpoints are perceived pain using a numeric pain rating scale and opioid consumption during the hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous SAPB | Active comparator | Drug: Continous SAPB (Ropivacain), Other: institutional standard of care pain medication protocolpostoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h) |
| Placebo | Placebo comparator | Other: institutional standard of care pain medication protocolstandard of care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Planned minimal invasive mitral valve repair via right anterior thoracotomy
Key exclusion criteria (5 listed)
- Pregenancy
- Opioid abuse
- Historyof chronic pain
- Allergy to local anaesthetics (in this case ropivacain)
- Patients who simultaneously participate in another interventional clinical trial, unless the Principal Investigators of the clinical trials give consent by mutual agreement Soft tissue infection in the area of the procedure
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 |
|---|---|---|
| Continous SAPB (Ropivacain)postoperative SAPB and pain catheter with continous administered (5ml/h Ropivacain 0,2%) for 48h | Drug | Continuous SAPB |
| institutional standard of care pain medication protocolinstitutional standard of care pain medication protocol | Other | Continuous SAPB, Placebo |
Primary outcome
Difference of Numeric Rating Scale after MIC-MKR
Time frame: within 12, 24 and 48 hours after surgery
Numeric Rating Scale (0-10, 0=smallest value, 10=greatest value)
1 secondary outcome
Difference of opioid consumption after MIC-MVR
Time frame: within 12, 24 and 48 hours after surgery
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 2 Oct 2025.
Related trials for Minimal Invasive Cardiac Surgery
Active, not recruitingObservational study
Coagulation Profiles in Conventional and Minimal Invasive Extracorporeal Circulation
Coagulation Changes During Coronary Artery Bypass Grafting
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
Not yet recruiting
Minimal Invasive Approaches For Aortic Valvular and Subvalvular Surgeries
Rheumatic Heart Disease With Valvulitis
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 study testing Continous SAPB (Ropivacain) in people with Minimal Invasive Cardiac Surgery and Minimal Invasive Cardiac Surgery Mitral Valve Surgery, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 2 Oct 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 Germany. 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.
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?
Difference of Numeric Rating Scale after MIC-MKR (time frame: within 12, 24 and 48 hours after surgery). 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 2 Oct 2025.