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| Name | Class |
|---|---|
| I. Heermann Anesthesia Foundation | UNKNOWN |
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Epidural analgesia via continuous epidurally infused local anesthetic agent (LA) is widely and very successfully used routinely for perioperative pain control in patients undergoing major orthopedic and abdominal surgery since 1928. The choice currently depends on the preference of the APS physician in charge of the case. A frequent unwanted side effect of epidural block is hypotension due to the epidurally injected LA blocking the sympathetic nerves and thus the patient's response to hypotension, which is usually due to hypovolemia and/or an unopposed parasympathetic (via the vagus nerve) nervous system. The purpose of this research study is to see if adding epinephrine, to the epidural anesthetic will decrease possible side effects, such as low blood pressure, and lead to a better effect of the epidural anesthetic.
Participants undergoing epidural analgesia to treat perioperative pain associated with major surgery will be approached for their willingness to participate in the study. Participants undergoing major thoracic, abdominal, or orthopaedic surgery for whom thoracic or lumbar epidural block would be indicated and planned for intraoperative and postoperative analgesia as per the University of Florida Acute Pain Service (APS) usual and routine practice will be included in this study.
All participants will receive a standardized continuous epidural block at the appropriate level for the planned surgery by the APS physicians in the block room that day. For the standardized continuous epidural block, placement will be confirmed with loss of resistance technique (LORA), wave form analysis or nerve stimulation.
Participants will be randomly allocated by computer-generated randomization to one of four groups. This will be a quintuple blinded prospective study. The anesthesiologist managing the intraoperative anesthesia, the anesthesiologists (APS) placing the blocks and following the participants on the floors, the research nurse taking the measurement, the surgeons, nor the participants will be aware of what combination of drugs are used for the epidural block infusion.
The three groups will consist of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine only Control group | Placebo Comparator | The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure. |
|
| Ropivacaine + 2 mcg/mL epinephrine | Active Comparator | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure. |
|
| Ropivacaine + 5 mcg/mL epinephrine | Active Comparator | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Hypotension will be assessed by systolic blood pressure (SBP) > 20% below the baseline preoperative measurements and acquired before the epidural or any sedation has been administered and the intra-operative period. The median time to end of intraoperative period was 2:37 (hours:min), ranging from 0:53 to 7:30. | Change from baseline to end of the intra-operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Spread of local anesthetic (block) effect as tested by sensitivity to cold recorded every hour postoperatively and every 8 hours for the subsequent 72 hours after discharge from the PACU. Cold was applied to dermatomes (i.e. segments/areas of skin primarily assoicated with one spinal nerve), then sensitivty to cold was recorded to determine spread of block across spinal segments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga C. Nin, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38991714 | Derived | Nin OC, Boezaart A, Giordano C, Hughes SJ, Parvataneni HK, Reina MA, Schirmer A, Vasilopoulos T. Pilot epinephrine dose-finding study to counter epidural-related blood pressure reduction. Reg Anesth Pain Med. 2025 Nov 5;50(11):901-906. doi: 10.1136/rapm-2024-105406. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine Only Control Group | The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. |
| FG001 | Ropivacaine + 2 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
| FG002 | Ropivacaine + 5 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine Only Control Group | The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. |
| BG001 |
| 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 | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Hypotension will be assessed by systolic blood pressure (SBP) > 20% below the baseline preoperative measurements and acquired before the epidural or any sedation has been administered and the intra-operative period. The median time to end of intraoperative period was 2:37 (hours:min), ranging from 0:53 to 7:30. | Posted | Count of Participants | Participants | Change from baseline to end of the intra-operative period |
|
Adverse events were recording across postoperative period until dishcarge
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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 | Ropivacaine Only Control Group | The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Terrie Vasilopoulos | University of Florida, College of Medicine | 3522738910 | tvasilopoulos@anest.ufl.edu |
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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 | Jun 9, 2016 | Mar 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Epinephrine | Drug | Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
|
|
| Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU) |
| Changes Between the 3 Groups Assessed by Ambulation After Surgery | Ambulation on post-op day 1, post-op day 2 and post-op day 3, will be recorded by distance ambulated per 24-hour period, calculating mean ambulation in feet per day | From post-operative (post-op) day 1 to post-op day 3 |
| Changes Between the 3 Groups Assessed by Opioid Usage | Opioid usage data will be recorded and converted to morphine equivalents and averaged for day 0, and post-op days 1, 2, and 3 per group. | From day of surgery (0) to post-op day 3 |
| Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Side effects such as pruritus, nausea/vomiting, and respiratory depression (defined as respiratory rate less than 10 breaths per minute of oxygen saturation more than 7 points lower that the patients preoperative value on room air) will be recorded. | From day of surgery (0) to post-op day 3 |
| Changes Between the 3 Groups Assessed by Fluid Balance | 24 hour intake and output for, the first 72 hours (up until POD 3) to assess fluid balance, reported as median intake and output per day (in milliliters per day). | From post-op day 1 to post-op day 3 |
| Changes Between the 3 Groups Assessed by Length of Hospitalization | Length of hospitalization, recorded as median days | post-op period, up until discharge |
| Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | Return to oral intake (PO) status, recorded in median days | post-op period, up until discharge |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | Changes in systolic blood pressure (SBP) , diastolic blood pressure (DBP), mean arterial blood pressure (MAP) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
| Differences Between the 3 Groups Assessed by Pain | Pain measured by and visual analog pain score on the Defense and Veterans Pain Rating Scale. This scale ranges from 0 to 10, with higher scores indicating greater pain. Pain scores were average within in 12-hour time interval for comparison. | Measured at 12-hour intervals for first 48 hours postopoerative |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | Changes in respiratory rate (RR) assesed by area-under-the-curve (AUC) calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | Changes in heart rate (HR) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | Changes in oxygen saturation (SpO2), and heart rate (HR) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
| Ropivacaine + 2 mcg/mL Epinephrine |
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
| BG002 | Ropivacaine + 5 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type of Surgery | Count of Participants | Participants |
|
| Type of Block | Count of Participants | Participants |
|
| Ropivacaine + 2 mcg/mL Epinephrine |
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
| OG002 | Ropivacaine + 5 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. |
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Spread of local anesthetic (block) effect as tested by sensitivity to cold recorded every hour postoperatively and every 8 hours for the subsequent 72 hours after discharge from the PACU. Cold was applied to dermatomes (i.e. segments/areas of skin primarily assoicated with one spinal nerve), then sensitivty to cold was recorded to determine spread of block across spinal segments. | Posted | Median | Inter-Quartile Range | dermatomes | Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU) |
|
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Ambulation After Surgery | Ambulation on post-op day 1, post-op day 2 and post-op day 3, will be recorded by distance ambulated per 24-hour period, calculating mean ambulation in feet per day | Posted | Mean | 95% Confidence Interval | feet per day | From post-operative (post-op) day 1 to post-op day 3 |
|
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Opioid Usage | Opioid usage data will be recorded and converted to morphine equivalents and averaged for day 0, and post-op days 1, 2, and 3 per group. | Putcome was only recorded for patients that remained hospitalized and does not included those that were discharged, thus lower numbers in later POD measurement. | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents | From day of surgery (0) to post-op day 3 |
|
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Side effects such as pruritus, nausea/vomiting, and respiratory depression (defined as respiratory rate less than 10 breaths per minute of oxygen saturation more than 7 points lower that the patients preoperative value on room air) will be recorded. | Outcome was was recorded up until POD 3. | Posted | Count of Participants | Participants | From day of surgery (0) to post-op day 3 |
|
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Fluid Balance | 24 hour intake and output for, the first 72 hours (up until POD 3) to assess fluid balance, reported as median intake and output per day (in milliliters per day). | change was measured earlier if discharge if before 72 hours. | Posted | Median | Full Range | milliliters per day | From post-op day 1 to post-op day 3 |
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Length of Hospitalization | Length of hospitalization, recorded as median days | Posted | Median | Full Range | days | post-op period, up until discharge |
|
|
|
| Secondary | Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | Return to oral intake (PO) status, recorded in median days | Posted | Median | Full Range | days | post-op period, up until discharge |
|
|
|
| Secondary | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | Changes in systolic blood pressure (SBP) , diastolic blood pressure (DBP), mean arterial blood pressure (MAP) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Posted | Mean | 95% Confidence Interval | mmHg * hours | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
|
|
|
|
| Secondary | Differences Between the 3 Groups Assessed by Pain | Pain measured by and visual analog pain score on the Defense and Veterans Pain Rating Scale. This scale ranges from 0 to 10, with higher scores indicating greater pain. Pain scores were average within in 12-hour time interval for comparison. | Posted | Mean | 95% Confidence Interval | units on a scale | Measured at 12-hour intervals for first 48 hours postopoerative |
|
|
|
|
| Secondary | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | Changes in respiratory rate (RR) assesed by area-under-the-curve (AUC) calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Posted | Mean | 95% Confidence Interval | breaths/min * hours | Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
|
|
|
|
| Secondary | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | Changes in heart rate (HR) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Posted | Mean | 95% Confidence Interval | beats/min * hours | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
|
|
|
|
| Secondary | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | Changes in oxygen saturation (SpO2), and heart rate (HR) assesed by area-under-the-curve calculated using pre-op as reference value. Measures were summarized across four time intervals, preoperative, intraoperative, PACU, and transfer to floor, with these intervals as x-axis for AUC | Posted | Mean | 95% Confidence Interval | % saturation * hours | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | Ropivacaine + 2 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. | 0 | 16 | 0 | 16 | 14 | 16 |
| EG002 | Ropivacaine + 5 mcg/mL Epinephrine | The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure. Ropivacaine: Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure. Epinephrine: Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment. | 0 | 16 | 0 | 16 | 14 | 16 |
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Respiratory Depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | RR less than 10bmp or Sa)2 sat >7pts below baseline |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Male |
|
| Orthopedia |
|
| Thoracic |
|
|
| POD 1 |
|
| 0.22 |
| Superiority |
| For POD 1 | Kruskal-Wallis | 0.74 | Superiority |
| POD 1 |
|
|
| POD 2 |
|
|
| POD 3 |
|
|
| Title | Measurements |
|---|---|
|
| Respiratory Depression |
|
| 0.44 |
| Superiority |
| For Respirartory Depression | Fisher Exact | 0.74 | Superiority |
|
| PO Intake |
|
| Urine Output |
|
|
| MAP |
|
| 0.585 |
| Superiority |
| For MAP | ANOVA | 0.199 | Superiority |
|
| 24-36 hours |
|
| 36-48 hours |
|