Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Not Applicable

Recruiting

• Conditions: Minimal Invasive Cardiac Surgery; Minimal Invasive Cardiac Surgery Mitral Valve Surgery; Serratus Anterior Plane Block
• Interventions: Drug: Continous SAPB (Ropivacain); Other: institutional standard of care pain medication protocol

• Registration Number: NCT05648266
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-13
• Last Update Posted: 2022-12-13
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

-Planned minimal invasive mitral valve repair via right anterior thoracotomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous SAPB	Continous SAPB (Ropivacain)	postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)
Continuous SAPB	institutional standard of care pain medication protocol	postoperative serratus-anterior-plane-block 20ml Ropivacain 0,75%, pain catheter with continous administered Ropivacain (5ml/h 0,2% for 48h)
Placebo	institutional standard of care pain medication protocol	standard of care

Primary Outcome Measures

Name	Time	Method
Analgesic effect of SAPB in MIC-MVR	within 48 hours after surgery	Numeric Pain Rating Scale

Secondary Outcome Measures

Name	Time	Method
Analgesic effect of SAPB in MIC-MVR	within 48 hours after surgery	Total opioid consumption in the intensive care unit

Trial Locations

Locations (1)

University Hospital Hamburg Eppendorf; 🇩🇪 Hamburg, Germany