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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 01/11/2021 | Other Identifier | UW Madison | |
| A530900 | Other Identifier | UW Madison | |
| SMPH/ANESTHESIOLOGY | Other Identifier | UW Madison |
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This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.
Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic.
The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB).
This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline).
The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIFB intervention | Experimental | bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) |
|
| Saline Control | Sham Comparator | bilateral PIFB with 25 mL saline only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Injection | Drug | 10mL of 0.25% bupivacaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption 72 Hours Post-operatively | Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups. | up to 72 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intraoperative Opioid Consumption | Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups. | intraoperative period ranging from anesthesia start time to anesthesia end time |
| Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Meyer, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40850695 | Derived | Simon ER, Mallery A, Silva J, de Biasi A, Osaki S, Krause BM, Meyer P. Superficial parasternal intercostal plane blocks with liposomal bupivacaine did not significantly reduce opioid use after cardiac surgery: a randomized clinical trial. Reg Anesth Pain Med. 2025 Aug 24:rapm-2025-106952. doi: 10.1136/rapm-2025-106952. Online ahead of print. |
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Participants were enrolled at UW Hospitals and Clinics from March 2022 until September 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | PIFB Intervention | bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) Bupivacaine Injection: 10mL of 0.25% bupivacaine Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine |
| FG001 | Saline Control | bilateral PIFB with 25 mL saline only Saline: 25mL saline control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PIFB Intervention | bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) Bupivacaine Injection: 10mL of 0.25% bupivacaine Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine |
| BG001 | Saline Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Total Opioid Consumption 72 Hours Post-operatively | Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | up to 72 hours post-operatively |
|
Participants were followed for up to 90 days following enrollment.
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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 | PIFB Intervention | bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) Bupivacaine Injection: 10mL of 0.25% bupivacaine Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Sullivan | University of Wisconsin - Madison | 6082639976 | jasullivan@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 11, 2021 | Nov 12, 2024 | Prot_SAP_ICF_003.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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prospective, single-center, randomized, double-blind, controlled trial
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Each study participant and OR anesthesia team, cardiac surgery team, cardiothoracic ICU team, and nursing staff caring for the participant will be blinded to the study drug the patient received. However, the anesthesia provider performing the block (separate from the provider caring for the patient in the operating room) will not be blinded to the study drug injected and will have access to all monitors deemed appropriate by the primary team caring for the participant.
| Liposomal bupivacaine |
| Drug |
15mL of 133mg liposomal bupivacaine |
|
| Saline | Other | 25mL saline control |
|
Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10). |
| data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively |
| Maximum Pain Scores up to 72 Hours Postoperatively | Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9). | up to 72 hours post-op |
| Pain Score at 90 Days Postoperatively | Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10). | up to 90 days post-op |
| Daily Opioid Consumption up to 72 Hours Postoperatively | Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups. | up to 72 hours post-op |
| Hours of Mechanical Ventilation After ICU Admission | Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU. | up to 72 hours post-op |
| Number of Postoperative Days Until the First Bowel Movement | Return of bowel function will be measured in the number of postoperative days until the first bowel movement. | up to 72 hours post-op |
| Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU) | Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined. | up to 72 hours post-op |
| Number of Hours That the Patient is in the ICU | Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care. | up to 72 hours post-op |
| Number of Post-operative Days Until the Patient is Discharged | Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged. | Up to 7 days |
| Count of Participants Using Opioids at 90 Days Postoperatively | Patient use of opioids at 90 days will be obtained by phone call. | up to 90 days post-op |
bilateral PIFB with 25 mL saline only Saline: 25mL saline control |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Intraoperative Opioid Consumption | Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups. | Posted | Median | Full Range | morphine milligram equivalents | intraoperative period ranging from anesthesia start time to anesthesia end time |
|
|
|
| Secondary | Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op | Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10). | Posted | Count of Participants | Participants | data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively |
|
|
|
| Secondary | Maximum Pain Scores up to 72 Hours Postoperatively | Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9). | Posted | Count of Participants | Participants | up to 72 hours post-op |
|
|
|
| Secondary | Pain Score at 90 Days Postoperatively | Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10). | Posted | Median | Inter-Quartile Range | pain score units on a scale | up to 90 days post-op |
|
|
|
| Secondary | Daily Opioid Consumption up to 72 Hours Postoperatively | Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups. | Posted | Median | Inter-Quartile Range | milligrams of morphine equivalents | up to 72 hours post-op |
|
|
|
| Secondary | Hours of Mechanical Ventilation After ICU Admission | Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU. | Posted | Median | Inter-Quartile Range | hours | up to 72 hours post-op |
|
|
|
| Secondary | Number of Postoperative Days Until the First Bowel Movement | Return of bowel function will be measured in the number of postoperative days until the first bowel movement. | Posted | Median | Inter-Quartile Range | days | up to 72 hours post-op |
|
|
|
| Secondary | Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU) | Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined. | Posted | Count of Participants | Participants | up to 72 hours post-op |
|
|
|
| Secondary | Number of Hours That the Patient is in the ICU | Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care. | Posted | Median | Inter-Quartile Range | hours | up to 72 hours post-op |
|
|
|
| Secondary | Number of Post-operative Days Until the Patient is Discharged | Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged. | Posted | Median | Full Range | days | Up to 7 days |
|
|
|
| Secondary | Count of Participants Using Opioids at 90 Days Postoperatively | Patient use of opioids at 90 days will be obtained by phone call. | Posted | Number | count of participants | up to 90 days post-op |
|
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Saline Control | bilateral PIFB with 25 mL saline only Saline: 25mL saline control | 0 | 50 | 0 | 50 | 0 | 50 |
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| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| high pain |
|
| Median pain scores at 48 hours post-operatively post-op |
|
| Median pain scores at 24 hours post-operatively |
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| Median Pain immediately post-operatively |
|
| Low Pain |
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| Within 24 hours, average pain |
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| Opioid Consumption between 48-72 hours post-operatively |
|