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Clinical Trials/NCT05648266
NCT05648266
Completed
Not Applicable

Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country78 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Continous SAPB (Ropivacain)
Conditions
Minimal Invasive Cardiac Surgery
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
78
Locations
1
Primary Endpoint
Difference of Numeric Rating Scale after MIC-MKR
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
July 1, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Continuous SAPB

postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)

Intervention: Continous SAPB (Ropivacain)

Continuous SAPB

postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)

Intervention: institutional standard of care pain medication protocol

Placebo

standard of care

Intervention: institutional standard of care pain medication protocol

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Difference of opioid consumption after MIC-MVR(within 12, 24 and 48 hours after surgery)

Study Sites (1)

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