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| Name | Class |
|---|---|
| Avanos Medical | OTHER |
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The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Infusion | Active Comparator | Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
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| Intermittent Bolus | Experimental | Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Infusion of ropivacaine | Drug | Continuous infusion of ropivacaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption POD 1 | Opioid consumption (MME) over the course of the first 24 hours following surgery | 0-24 hours post-op |
| Opioid Consumption POD 2 | Opioid consumption (MME) over the course of the 48 hours following surgery | 24-48 hours post-op |
| Opioid Consumption POD 3 | Opioid consumption (MME) over the course of the 48-72 hours following surgery | 48-72 hours post-op |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Score POD 1 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op | 0-24 hrs post-op |
| NRS Pain Score POD 2 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48201 | United States |
We will not make individual participant data available to other researchers.
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All subjects who consented to participate in the study were randomized to one of the two groups.
Subjects were recruited from October 18th, 2022 through December 19th, 2024 from a large academic hospital in the midwestern United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Infusion | Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
| FG001 | Intermittent Bolus | Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| Allocation |
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| Follow-Up |
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| Analysis |
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The baseline analysis included subjects who completed their treatment arm. Subjects who were withdrawn for any reason were excluded from the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Infusion | Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
| BG001 | Intermittent Bolus |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age |
| 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 | Opioid Consumption POD 1 | Opioid consumption (MME) over the course of the first 24 hours following surgery | Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis). | Posted | Mean | Standard Deviation | MME | 0-24 hours post-op |
|
0-72 hours post-op
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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 | Continuous Infusion | Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Forrest, MD | Henry Ford Health System | 313-717-0125 | pforres1@hfhs.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 | Jan 31, 2025 | Dec 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)
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The only people who will know the treatment arm that has been assigned to the participant are the research coordinator who randomized them and the regional anesthesia team. The patient, nursing team, and research coordinator performing outcomes assessments will all be blinded to the treatment group.
| Intermittent bolus of ropivacaine |
| Drug |
Intermittent bolus of ropivacaine |
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| 24-48 hrs post-op |
| NRS Pain Score POD 3 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op | 48-72 hrs post-op |
| ICU Length of Stay | Time from post-op to step-down from ICU | 7 days post-op |
| Quality of Recovery 15 (QoR-15) Score POD 1 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1. | 0-24 hours post-op |
| Quality of Recovery 15 (QoR-15) Score POD 2 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2. | 24-48 hours post-op |
| Quality of Recovery 15 (QoR-15) Score POD 3 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3. | 48-72 hours post-op |
| Time to First Antiemetic | Time to first antiemetic post-op | 0-200 hours post-op |
| Time to First Bowel Movement | Time to first bowel movement post-op | 0-72 hours post-op |
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Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Sex: female, male | Count of Participants | Participants |
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| Race (NIH/OMB) | Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index | Body mass index | Mean | Standard Deviation | kg/m^2 |
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| Secondary | NRS Pain Score POD 1 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op | Some participants in the continuous infusion arm were not able to provide NRS pain scores during their first 24 hours post-op. | Posted | Mean | Standard Deviation | units on a scale | 0-24 hrs post-op |
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| Secondary | NRS Pain Score POD 2 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2 | One participant in the continuous infusion arm was not able to provide NRS pain scores on POD 2. | Posted | Mean | Standard Deviation | units on a scale | 24-48 hrs post-op |
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| Secondary | NRS Pain Score POD 3 | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op | One participant in the intermittent bolus arm was not able to provide NRS pain scores on POD 3. | Posted | Mean | Standard Deviation | units on a scale | 48-72 hrs post-op |
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| Secondary | ICU Length of Stay | Time from post-op to step-down from ICU | Posted | Mean | Standard Deviation | days | 7 days post-op |
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| Primary | Opioid Consumption POD 2 | Opioid consumption (MME) over the course of the 48 hours following surgery | Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis). | Posted | Mean | Standard Deviation | MME | 24-48 hours post-op |
|
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| Primary | Opioid Consumption POD 3 | Opioid consumption (MME) over the course of the 48-72 hours following surgery | Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis). | Posted | Mean | Standard Deviation | MME | 48-72 hours post-op |
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| Secondary | Quality of Recovery 15 (QoR-15) Score POD 1 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1. | Some subjects were unable to complete the QoR-15 on POD 1 because they remained intubated. | Posted | Mean | Standard Deviation | units on a scale | 0-24 hours post-op |
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| Secondary | Quality of Recovery 15 (QoR-15) Score POD 2 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2. | Some subjects were unable to complete the QoR-15 on POD 2 because they remained intubated. | Posted | Mean | Standard Deviation | units on a scale | 24-48 hours post-op |
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| Secondary | Quality of Recovery 15 (QoR-15) Score POD 3 | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3. | Some subjects in both arms were unable to complete the QoR-15 on POD 3. | Posted | Mean | Standard Deviation | units on a scale | 48-72 hours post-op |
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| Secondary | Time to First Antiemetic | Time to first antiemetic post-op | Posted | Mean | Standard Deviation | hours | 0-200 hours post-op |
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| Secondary | Time to First Bowel Movement | Time to first bowel movement post-op | Posted | Mean | Standard Deviation | hours | 0-72 hours post-op |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | Intermittent Bolus | Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. | 0 | 108 | 0 | 108 | 0 | 108 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |