Serratus Plane Block After Minimally Invasive Mitral Valve Repair

• Sponsor: Universitätsklinikum Hamburg-Eppendorf (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05648266
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Minimal Invasive Cardiac Surgery; Minimal Invasive Cardiac Surgery Mitral Valve Surgery; Serratus Anterior Plane Block	Drug: Continous SAPB (Ropivacain); Other: institutional standard of care pain medication protocol	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Serratus Plane Block After Minimally Invasive Mitral Valve Repair
• Actual Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Continuous SAPB 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); 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
Placebo Comparator: Placebo standard of care	Other: institutional standard of care pain medication protocol; institutional standard of care pain medication protocol

Outcome Measures

Primary Outcome Measures

1. Analgesic effect of SAPB in MIC-MVR [within 48 hours after surgery]

   Numeric Pain Rating Scale

Secondary Outcome Measures

1. Analgesic effect of SAPB in MIC-MVR [within 48 hours after surgery]

   Total opioid consumption in the intensive care unit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Hamburg Eppendorf	Hamburg		Germany	20251

Sponsors and Collaborators

• Universitätsklinikum Hamburg-Eppendorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT05648266
• Other Study ID Numbers: 19518181202119
• First Posted: Dec 13, 2022
• Last Update Posted: Dec 13, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Analgesics

Study Results

No Results Posted as of Dec 13, 2022