Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Continuous SAPB

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

Group Type ACTIVE_COMPARATOR

Continous SAPB (Ropivacain)

Intervention Type DRUG

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

institutional standard of care pain medication protocol

Intervention Type OTHER

institutional standard of care pain medication protocol

Placebo

standard of care

Group Type PLACEBO_COMPARATOR

institutional standard of care pain medication protocol

Intervention Type OTHER

institutional standard of care pain medication protocol

Interventions

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Continous SAPB (Ropivacain)

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

Intervention Type DRUG

institutional standard of care pain medication protocol

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No