Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Serratus Anterior Plane Block Clinical Trial

Official title:

Serratus Plane Block After Minimally Invasive Mitral Valve Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648266
• Other study ID #: 19518181202119
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Niklas Neumann, Dr.
• Phone: 004915222844008
• Email: n.neumann[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Serratus Anterior Plane Block

Intervention

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

Other:
• institutional standard of care pain medication protocol
institutional standard of care pain medication protocol

Locations

Country	Name	City	State
Germany	University Hospital Hamburg Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic effect of SAPB in MIC-MVR	Numeric Pain Rating Scale	within 48 hours after surgery
Secondary	Analgesic effect of SAPB in MIC-MVR	Total opioid consumption in the intensive care unit	within 48 hours after surgery