Pectoralis and Serratus Muscle Blocks

Post Operative Pain Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743194
• Other study ID #: 18-1125
• Status: Completed
• Phase: Phase 4
• Start date: December 14, 2021
• Est. completion date: March 14, 2022

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the minimal clinically important benefit.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 14, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 18-85 years old;

2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain Control

Intervention

Drug:
• Exparel 266 MG Per 20 ML Injection
The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.
• Placebo
Patients randomized to standard analgesia technique will be given pain medications.

Locations

Country	Name	City	State
United States	The Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Benefit Analgesia Score	Our primary outcome, Overall Benefit Analgesia Score (OBAS), was measured daily by investigators blinded to treatment on postoperative Days 1 to 3.Potential scores of the seven-item questionnaire ranged from 0 to 28 points. Higher scores means worse conditions.	Postoperative day 1-3
Secondary	Cumulative Opioid Consumption Over Postoperative 3 Days	Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)	72 hours postoperative
Secondary	Postoperative FEV1	Pulmonary Mechanics measure: The FEV1 (forced expiratory volume in 1 seconds) in litters, measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.	Postoperatively day 1 -3
Secondary	Postoperative FVC	Pulmonary Mechanics measure: the FVC (Forced Vital Capacity) in litters will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.	Postoperative day 1 -3
Secondary	Postoperative Peak Flow	Pulmonary Mechanics measure: the peak flow (peak expiratory flow) in litters per second will be measured using Easy on-PC Spirometry System (ndd Medical, Andover MA) with the patient in the sitting position. Measurements will be done on postoperative mornings 1, 2 and 3. The average of 3 days measurement will be calculated.	Postoperative day 1-3