Pectoralis and Serratus Muscle Blocks



Status:Recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 85
Updated:1/10/2019
Start Date:December 1, 2018
End Date:December 2020
Contact:Andrej Alfirevic, MD
Email:alfirea@ccf.org
Phone:216-444-9383

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Pectoralis and Serratus Muscle Blocks for Analgesia After Minimally Invasive Cardiac Procedures

The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall
Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 2-point reduction
in OBAS will be considered the minimal clinically important benefit.

The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and
liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral
analgesia in patients recovering from MICS. The primary outcome will be the simple
multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our
secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain
medications administered over one-day periods quantified as morphine equivalents and provided
by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory
mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and
peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain
hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1,
2 and 3.

Inclusion Criteria:

1. 18-85 years old;

2. Elective MICS for isolated aortic or mitral valve via anterior or anterolateral
thoracotomy approach with or without robotic assistance.

Exclusion Criteria:

1. Weight less than 50 kg;

2. Pregnancy or lactation;

3. Emergency surgery and patients transferred from the ICU to the operating room;

4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index
procedure (including minor chest wall procedures including tube thoracostomy,
thoracentesis or percutaneous drain placement);

5. Anticipated endotracheal intubation > 24 hours;

6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;

7. Active systemic or cardiopulmonary infection;

8. Mechanical circulatory support;

9. Allergy or contraindication to study local anesthetics;

10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like
Percocet or Vicodin) in a dose of > 30 mg of morphine-milligram-equivalents for at
least 10 days in last 30 days;

11. Poorly controlled psychiatric disorders;

12. Clinically important current neurologic deficit;

13. Active liver disease or cirrhosis;

14. Pacemaker generator or breast implants ipsilateral to surgery;

15. Previous participation in this study.
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-444-9950
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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