- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743194
Pectoralis and Serratus Muscle Blocks
December 11, 2023 updated by: The Cleveland Clinic
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- The Cleveland Clinic Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-85 years old;
- Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy
Exclusion Criteria:
- Weight less than 50 kg;
- Pregnancy or lactation;
- Emergency surgery and patients transferred from the ICU to the operating room;
- 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);
- Anticipated endotracheal intubation > 24 hours;
- Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
- Active systemic or cardiopulmonary infection;
- Mechanical circulatory support;
- Allergy or contraindication to study local anesthetics;
- 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;
- Poorly controlled psychiatric disorders;
- Clinically important current neurologic deficit;
- Active liver disease or cirrhosis;
- Pacemaker generator or breast implants ipsilateral to surgery;
- Previous participation in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupi HCl plus liposomal bupi
Pectoral fascial plane or serratus anterior plane blocks (PECSII/SAP blocks) with bupivacaine HCl plus liposomal bupivacaine. An ultrasound guided pectoral fascial plane blocks (PECS I and II blocks) and Serratus anterior plane (SAP) block with injection of the local anesthetic. |
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.
Other Names:
Patients randomized to standard analgesia technique will be given pain medications.
Other Names:
|
Placebo Comparator: Control Group
Standard parenteral analgesia technique with or without incisional local anesthetic infiltration: patients randomized to control group will be given parenteral opioids (such as fentanyl or hydromorphone) until they are converted to the enteral medications such as Percocet.
|
Patients randomized to standard analgesia technique will be given pain medications.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Benefit Analgesia Score
Time Frame: Postoperative day 1-3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Opioid Consumption Over Postoperative 3 Days
Time Frame: 72 hours postoperative
|
Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents)
|
72 hours postoperative
|
Postoperative FEV1
Time Frame: Postoperatively day 1 -3
|
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
|
Postoperative FVC
Time Frame: Postoperative day 1 -3
|
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
|
Postoperative Peak Flow
Time Frame: Postoperative day 1-3
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrej Alfirevic, MD, The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2021
Primary Completion (Actual)
February 28, 2022
Study Completion (Actual)
March 14, 2022
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-1125
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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