Serratus Plane Block After Minimally Invasive Mitral Valve Repair

NCT05648266 | Completed

• 1 other identifier: 19518181202119
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Difference of Numeric Rating Scale after MIC-MKR

  Numeric Rating Scale (0-10, 0=smallest value, 10=greatest value)

  within 12, 24 and 48 hours after surgery

Secondary Outcomes (1)

• Difference of opioid consumption after MIC-MVR

  within 12, 24 and 48 hours after surgery

Study Arms (2)

Continuous SAPB

ACTIVE COMPARATOR

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

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

Placebo

PLACEBO COMPARATOR

standard of care

Other: institutional standard of care pain medication protocol

Interventions

Continous SAPB (Ropivacain) DRUG

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

Continuous SAPB

institutional standard of care pain medication protocol OTHER

institutional standard of care pain medication protocol

Continuous SAPB; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned minimal invasive mitral valve repair via right anterior thoracotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg Eppendorf

Hamburg, Hamburg, 20251, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: April 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

DE (1)