Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Minimal Invasive Cardiac Surgery Mitral Valve Surgery; Serratus Anterior Plane Block; Minimal Invasive Cardiac Surgery

Treatments: Other: institutional standard of care pain medication protocol; Drug: Continous SAPB (Ropivacain)

Study type: Interventional

Funder types: Other

Identifiers

NCT05648266

19518181202119

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Continuous SAPB

Active Comparator group

Description:

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

Treatment:

Drug: Continous SAPB (Ropivacain)

Other: institutional standard of care pain medication protocol

Placebo

Placebo Comparator group

Description:

standard of care

Treatment:

Other: institutional standard of care pain medication protocol