Hypotension, Pain
Conditions
Keywords
Epidural Analgesia
Brief summary
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.
Detailed description
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: 1. Group A (Ropivacaine 0.2% infusion; Control group) 2. Group B (Ropivacaine 0.2% + 2 mcg/mL epinephrine) 3. Group C (Ropivacaine 0.2% + 5 mcg/mL epinephrine)
Interventions
DRUGRopivacaine
Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.
DRUGEpinephrine
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.
Sponsors
I. Heermann Anesthesia Foundation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* undergoing epidural analgesia to treat perioperative pain associated with major surgery * undergoing major thoracic surgery * undergoing major abdominal surgery * undergoing major orthopaedic surgery
Exclusion criteria
* sepsis * acute trauma * coagulopathy * preoperative hemodynamic instability * symptomatic coronary artery disease * patients from the ICU whose tracheas were intubated for any cause * allergies to medications in the protocol * primary or secondary block failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Change from baseline to end of the intra-operative period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU) | 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. |
| Changes Between the 3 Groups Assessed by Ambulation After Surgery | From post-operative (post-op) day 1 to post-op day 3 | 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 |
| Changes Between the 3 Groups Assessed by Opioid Usage | From day of surgery (0) to post-op day 3 | 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. |
| Changes Between the 3 Groups Assessed by Opioid-related Side Effects | From day of surgery (0) to post-op day 3 | 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. |
| Changes Between the 3 Groups Assessed by Fluid Balance | From post-op day 1 to post-op day 3 | 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). |
| Changes Between the 3 Groups Assessed by Length of Hospitalization | post-op period, up until discharge | Length of hospitalization, recorded as median days |
| Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | post-op period, up until discharge | Return to oral intake (PO) status, recorded in median days |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) | 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 |
| Differences Between the 3 Groups Assessed by Pain | Measured at 12-hour intervals for first 48 hours postopoerative | 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. |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) | 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 |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) | 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 |
| Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 16 |
| 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. | 16 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 8 | 4 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Ropivacaine Only Control Group | Ropivacaine + 2 mcg/mL Epinephrine | Ropivacaine + 5 mcg/mL Epinephrine | Total |
|---|---|---|---|---|
| Age, Continuous | 59.5 Years STANDARD_DEVIATION 14.2 | 52.8 Years STANDARD_DEVIATION 16.8 | 57.3 Years STANDARD_DEVIATION 14.5 | 58.7 Years STANDARD_DEVIATION 14.2 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 9 Participants | 25 Participants |
| Type of Block Lumbar | 6 Participants | 9 Participants | 4 Participants | 19 Participants |
| Type of Block Thoracic | 9 Participants | 7 Participants | 12 Participants | 28 Participants |
| Type of Surgery Abdominal | 9 Participants | 7 Participants | 12 Participants | 28 Participants |
| Type of Surgery Orthopedia | 6 Participants | 9 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 12 / 15 | 14 / 16 | 14 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Change from baseline to end of the intra-operative period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Hypotension | 5 Participants |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | No Hypotension | 10 Participants |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Hypotension | 2 Participants |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | No Hypotension | 14 Participants |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | Hypotension | 3 Participants |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Blood Pressure Measurement | No Hypotension | 13 Participants |
p-value: 0.16595% CI: [-8.9, 47.3]Z-test for proportions
p-value: 0.35395% CI: [-15.9, 42.2]Z-test for proportions
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
Time frame: From post-operative (post-op) day 1 to post-op day 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Ambulation After Surgery | 125.5 feet per day |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Ambulation After Surgery | 90.2 feet per day |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Ambulation After Surgery | 139.1 feet per day |
p-value: 0.551ANOVA
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
Time frame: post-op period, up until discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | 1 days |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | 1 days |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status | 1 days |
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).
Time frame: From post-op day 1 to post-op day 3
Population: change was measured earlier if discharge if before 72 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Fluid Balance | Drain Output | 164 milliliters per day |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Fluid Balance | IV Intake | 2428 milliliters per day |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Fluid Balance | PO Intake | 542 milliliters per day |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Fluid Balance | Urine Output | 1921 milliliters per day |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | Urine Output | 1600 milliliters per day |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | Drain Output | 305 milliliters per day |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | PO Intake | 308 milliliters per day |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | IV Intake | 1300 milliliters per day |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | Urine Output | 1100 milliliters per day |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | IV Intake | 1843 milliliters per day |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | PO Intake | 477 milliliters per day |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Fluid Balance | Drain Output | 315 milliliters per day |
Secondary
Changes Between the 3 Groups Assessed by Length of Hospitalization
Length of hospitalization, recorded as median days
Time frame: post-op period, up until discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Length of Hospitalization | 4 days |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Length of Hospitalization | 2 days |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Length of Hospitalization | 2 days |
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.
Time frame: From day of surgery (0) to post-op day 3
Population: Outcome was was recorded up until POD 3.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Nausea/vomiting | 5 Participants |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Pruritis | 1 Participants |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Respiratory Depression | 12 Participants |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Nausea/vomiting | 8 Participants |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Pruritis | 5 Participants |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Respiratory Depression | 12 Participants |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Pruritis | 1 Participants |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Respiratory Depression | 14 Participants |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid-related Side Effects | Nausea/vomiting | 9 Participants |
Comparison: For Pruritisp-value: 0.18Fisher Exact
Comparison: For Nausea/Vomitingp-value: 0.44Fisher Exact
Comparison: For Respirartory Depressionp-value: 0.74Fisher Exact
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.
Time frame: From day of surgery (0) to post-op day 3
Population: Putcome was only recorded for patients that remained hospitalized and does not included those that were discharged, thus lower numbers in later POD measurement.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid Usage | POD 0 | 27.2 Morphine milligram equivalents |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid Usage | POD 1 | 41.9 Morphine milligram equivalents |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid Usage | POD 2 | 28.0 Morphine milligram equivalents |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by Opioid Usage | POD 3 | 45.5 Morphine milligram equivalents |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 3 | 19.8 Morphine milligram equivalents |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 0 | 40.4 Morphine milligram equivalents |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 2 | 47.5 Morphine milligram equivalents |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 1 | 65.1 Morphine milligram equivalents |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 3 | 26.9 Morphine milligram equivalents |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 1 | 28.3 Morphine milligram equivalents |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 2 | 26.7 Morphine milligram equivalents |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by Opioid Usage | POD 0 | 14.9 Morphine milligram equivalents |
p-value: 0.349Mixed Models Analysis
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.
Time frame: Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Pre-op | 10 dermatomes |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | PACU | 8 dermatomes |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | POD 1 | 7 dermatomes |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Pre-op | 9 dermatomes |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | PACU | 11 dermatomes |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | POD 1 | 6 dermatomes |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | PACU | 9 dermatomes |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | POD 1 | 8 dermatomes |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect | Pre-op | 7 dermatomes |
Comparison: For PACU spreadp-value: 0.06Kruskal-Wallis
Comparison: For Pre-op spreadp-value: 0.22Kruskal-Wallis
Comparison: For POD 1p-value: 0.74Kruskal-Wallis
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
Time frame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | DBP | -0.3 mmHg * hours |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | SBP | -9.6 mmHg * hours |
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | MAP | 6.4 mmHg * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | DBP | -6.1 mmHg * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | SBP | -5.0 mmHg * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | MAP | -6.4 mmHg * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | SBP | -4.5 mmHg * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | MAP | -11.6 mmHg * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure | DBP | -8.2 mmHg * hours |
Comparison: For SBPp-value: 0.524ANOVA
Comparison: For DBPp-value: 0.585ANOVA
Comparison: For MAPp-value: 0.199ANOVA
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
Time frame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | 17.3 beats/min * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | -2.1 beats/min * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate | 0.9 beats/min * hours |
p-value: 0.055ANOVA
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
Time frame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | 11.5 % saturation * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | 1.8 % saturation * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation | 0.3 % saturation * hours |
p-value: 0.567ANOVA
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
Time frame: Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine Only Control Group | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | -10.2 breaths/min * hours |
| Ropivacaine + 2 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | -4.2 breaths/min * hours |
| Ropivacaine + 5 mcg/mL Epinephrine | Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate | -3.6 breaths/min * hours |
p-value: 0.016ANOVA
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.
Time frame: Measured at 12-hour intervals for first 48 hours postopoerative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ropivacaine Only Control Group | Differences Between the 3 Groups Assessed by Pain | 24-36 hours | 4.3 units on a scale |
| Ropivacaine Only Control Group | Differences Between the 3 Groups Assessed by Pain | 36-48 hours | 3.0 units on a scale |
| Ropivacaine Only Control Group | Differences Between the 3 Groups Assessed by Pain | 12-24 hours | 4.4 units on a scale |
| Ropivacaine Only Control Group | Differences Between the 3 Groups Assessed by Pain | 0-12 hours | 3.5 units on a scale |
| Ropivacaine + 2 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 0-12 hours | 2.5 units on a scale |
| Ropivacaine + 2 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 12-24 hours | 3.9 units on a scale |
| Ropivacaine + 2 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 36-48 hours | 3.7 units on a scale |
| Ropivacaine + 2 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 24-36 hours | 4.3 units on a scale |
| Ropivacaine + 5 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 36-48 hours | 3.6 units on a scale |
| Ropivacaine + 5 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 0-12 hours | 4.3 units on a scale |
| Ropivacaine + 5 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 12-24 hours | 3.9 units on a scale |
| Ropivacaine + 5 mcg/mL Epinephrine | Differences Between the 3 Groups Assessed by Pain | 24-36 hours | 3.5 units on a scale |
p-value: 0.231Mixed Models Analysis