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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupi HCl plus liposomal bupi | Active Comparator | 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. |
|
| Control Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel 266 MG Per 20 ML Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Opioid Consumption Over Postoperative 3 Days | Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents) | 72 hours postoperative |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Alfirevic, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37055276 | Derived | Alfirevic A, Marciniak D, Duncan AE, Kelava M, Yalcin EK, Hamadnalla H, Pu X, Sessler DI, Bauer A, Hargrave J, Bustamante S, Gillinov M, Wierup P, Burns DJP, Lam L, Turan A. Serratus anterior and pectoralis plane blocks for robotically assisted mitral valve repair: a randomised clinical trial. Br J Anaesth. 2023 Jun;130(6):786-794. doi: 10.1016/j.bja.2023.02.038. Epub 2023 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine HCl plus liposomal bupivacaine | The treatment group received 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. 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. |
| FG001 | 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. Placebo: Patients randomized to standard analgesia technique will be given pain medications. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine HCl plus liposomal bupivacaine | The treatment group received 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Some were some missing on each groups at each day during POD1- POD3. But since the statistical analysis used mixed model thus it could deal with missing as long as patients were not completely missing on all postoperative 3 days. Only 1 patient was missing on all postoperative 3 days, his outcome was imputed. | Posted | Median | Inter-Quartile Range | score on a scale | Postoperative day 1-3 |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine HCl plus liposomal bupivacaine | The treatment group received 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xuan Pu | The Cleveland Clinic Foundation | 216 444-8013 | PuX@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2022 | Sep 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
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| Placebo | Drug | Patients randomized to standard analgesia technique will be given pain medications. |
|
|
| Postoperatively day 1 -3 |
| 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 |
| 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 |
| BG001 | 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. Placebo: Patients randomized to standard analgesia technique will be given pain medications. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ASA status | The ASA Physical Status Classification System has been in use for over 60 years. The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning), it can be helpful in predicting perioperative risks. ASA takes values from I to VI, representing from a normal healthy patient to a declared brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Coronary arterial disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Previous myocardial infarction | Count of Participants | Participants |
|
| Previous vascular disease | Count of Participants | Participants |
|
| Cerebrovascular disease | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Renal failure | Count of Participants | Participants |
|
| Left ventricular EF (% of ejection fraction) | Ejection fraction is measured as a percentage of the total amount of blood in your heart that is pumped out with each heartbeat | Median | Inter-Quartile Range | %of blood pumped out from left ventricle |
|
| Baseline peak flow | Mean | Standard Deviation | L/s |
|
| Baseline FEV1 | Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. Higher values suggests better lung function. | Mean | Standard Deviation | L |
|
| Baseline FVC | Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. Higher values indicate better lung function. | Mean | Standard Deviation | L |
|
| OG001 | 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. Placebo: Patients randomized to standard analgesia technique will be given pain medications. |
|
|
|
| Secondary | Cumulative Opioid Consumption Over Postoperative 3 Days | Cumulative 72-hour postoperative opioid consumption (mg IV morphine equivalents) | Posted | Median | Inter-Quartile Range | mg 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. | Some patients were missing on some measurements during POD1-POD3. | Posted | Mean | Standard Deviation | L | 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. | Some patients were missing on measurements during POD 1-POD3. | Posted | Mean | Standard Deviation | L | 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. | Some patients were missing on some measurements during POD1-POD3. | Posted | Mean | Standard Deviation | L/s | Postoperative day 1-3 |
|
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | 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. Placebo: Patients randomized to standard analgesia technique will be given pain medications. | 0 | 96 | 0 | 96 | 0 | 96 |
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| POD2 |
|
|
| POD3 |
|
|
The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. |
| Linear mixed model |
| 0.79 |
| Mean Difference (Final Values) |
| -0.02 |
| 2-Sided |
| 99.6 |
| -0.26 |
| 0.22 |
| Superiority |
Difference in mean at POD2 |
| The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. | Linear mixed model | 0.39 | Mean Difference (Final Values) | -0.07 | 2-Sided | 99.6 | -0.31 | 0.17 | Superiority | Difference in mean at POD3 |
| POD2 |
|
|
| POD3 |
|
|
The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. |
| Linear mixed model |
| 0.91 |
Mean difference at POD2 |
| Mean Difference (Final Values) |
| -0.01 |
| 2-Sided |
| 99.6 |
| -0.33 |
| 0.30 |
| Superiority |
| The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. | Linear mixed model | 0.31 | Mean Difference (Final Values) | -0.11 | 2-Sided | 99.6 | -0.43 | 0.21 | Superiority | Difference in mean at POD3 |
| POD2 |
|
|
| POD3 |
|
|
The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. |
| Linear mixed model |
| 0.97 |
| Mean Difference (Final Values) |
| 0.01 |
| 2-Sided |
| 99.6 |
| -0.66 |
| 0.67 |
| Superiority |
| The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction. | Linear mixed model | 0.36 | Mean Difference (Final Values) | -0.21 | 2-Sided | 99.6 | -0.88 | 0.46 | Superiority | Difference in means at POD3 |