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Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05648266
Enrollment
78
Registered
2022-12-13
Start date
2022-04-01
Completion date
2024-07-01
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Invasive Cardiac Surgery, Minimal Invasive Cardiac Surgery Mitral Valve Surgery, Serratus Anterior Plane Block

Brief 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. 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.

Interventions

DRUGContinous SAPB (Ropivacain)

postoperative SAPB and pain catheter with continous administered (5ml/h Ropivacain 0,2%) for 48h

OTHERinstitutional standard of care pain medication protocol

institutional standard of care pain medication protocol

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

-Planned minimal invasive mitral valve repair via right anterior thoracotomy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Difference of Numeric Rating Scale after MIC-MKRwithin 12, 24 and 48 hours after surgeryNumeric Rating Scale (0-10, 0=smallest value, 10=greatest value)

Secondary

MeasureTime frameDescription
Difference of opioid consumption after MIC-MVRwithin 12, 24 and 48 hours after surgerydaily, cumulative dose of opioid analgetic medication after MIC-MKR

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026