Trial Outcomes & Findings for The Prevention of Hypotension After Epidural Analgesia After Major Surgery (NCT NCT02722746)
NCT ID: NCT02722746
Last Updated: 2025-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Change from baseline to end of the intra-operative period
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
22
|
|
Overall Study
COMPLETED
|
15
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
8
|
4
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 14.2 • n=15 Participants
|
52.8 Years
STANDARD_DEVIATION 16.8 • n=16 Participants
|
57.3 Years
STANDARD_DEVIATION 14.5 • n=16 Participants
|
58.7 Years
STANDARD_DEVIATION 14.2 • n=47 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
7 Participants
n=16 Participants
|
7 Participants
n=16 Participants
|
22 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=15 Participants
|
9 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
25 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Type of Surgery
Abdominal
|
9 Participants
n=15 Participants
|
7 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
28 Participants
n=47 Participants
|
|
Type of Surgery
Orthopedia
|
6 Participants
n=15 Participants
|
9 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
19 Participants
n=47 Participants
|
|
Type of Block
Lumbar
|
6 Participants
n=15 Participants
|
9 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
19 Participants
n=47 Participants
|
|
Type of Block
Thoracic
|
9 Participants
n=15 Participants
|
7 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
28 Participants
n=47 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to end of the intra-operative periodHypotension 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.
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Blood Pressure Measurement
Hypotension
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Changes Between the 3 Groups Assessed by Blood Pressure Measurement
No Hypotension
|
10 Participants
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=14 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=12 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=14 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect
PACU
|
8 dermatomes
Interval 6.0 to 9.0
|
11 dermatomes
Interval 8.0 to 13.0
|
9 dermatomes
Interval 7.0 to 10.0
|
|
Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect
Pre-op
|
10 dermatomes
Interval 9.0 to 12.0
|
9 dermatomes
Interval 7.0 to 11.0
|
7 dermatomes
Interval 5.0 to 10.0
|
|
Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect
POD 1
|
7 dermatomes
Interval 7.0 to 10.0
|
6 dermatomes
Interval 6.0 to 10.0
|
8 dermatomes
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: From post-operative (post-op) day 1 to post-op day 3Ambulation 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
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=13 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=14 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=13 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Ambulation After Surgery
|
125.5 feet per day
Interval 58.3 to 192.7
|
90.2 feet per day
Interval 25.5 to 155.0
|
139.1 feet per day
Interval 71.9 to 206.3
|
SECONDARY outcome
Timeframe: From day of surgery (0) to post-op day 3Population: Putcome was only recorded for patients that remained hospitalized and does not included those that were discharged, thus lower numbers in later POD measurement.
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.
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Opioid Usage
POD 0
|
27.2 Morphine milligram equivalents
Interval 1.7 to 52.7
|
40.4 Morphine milligram equivalents
Interval 16.7 to 64.2
|
14.9 Morphine milligram equivalents
Interval -7.4 to 37.2
|
|
Changes Between the 3 Groups Assessed by Opioid Usage
POD 1
|
41.9 Morphine milligram equivalents
Interval 16.2 to 67.6
|
65.1 Morphine milligram equivalents
Interval 39.4 to 90.8
|
28.3 Morphine milligram equivalents
Interval 4.2 to 53.1
|
|
Changes Between the 3 Groups Assessed by Opioid Usage
POD 2
|
28.0 Morphine milligram equivalents
Interval 4.9 to 51.1
|
47.5 Morphine milligram equivalents
Interval 26.4 to 68.6
|
26.7 Morphine milligram equivalents
Interval 6.4 to 47.0
|
|
Changes Between the 3 Groups Assessed by Opioid Usage
POD 3
|
45.5 Morphine milligram equivalents
Interval 6.8 to 84.6
|
19.8 Morphine milligram equivalents
Interval -35.0 to 74.6
|
26.9 Morphine milligram equivalents
Interval -17.8 to 71.7
|
SECONDARY outcome
Timeframe: From day of surgery (0) to post-op day 3Population: Outcome was was recorded up until POD 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.
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Opioid-related Side Effects
Pruritis
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Changes Between the 3 Groups Assessed by Opioid-related Side Effects
Nausea/vomiting
|
5 Participants
|
8 Participants
|
9 Participants
|
|
Changes Between the 3 Groups Assessed by Opioid-related Side Effects
Respiratory Depression
|
12 Participants
|
12 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From post-op day 1 to post-op day 3Population: change was measured earlier if discharge if before 72 hours.
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).
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Fluid Balance
Drain Output
|
164 milliliters per day
Interval 0.0 to 1635.0
|
305 milliliters per day
Interval 109.0 to 458.0
|
315 milliliters per day
Interval 0.0 to 2162.0
|
|
Changes Between the 3 Groups Assessed by Fluid Balance
IV Intake
|
2428 milliliters per day
Interval 872.0 to 4185.0
|
1300 milliliters per day
Interval 700.0 to 3615.0
|
1843 milliliters per day
Interval 512.0 to 3859.0
|
|
Changes Between the 3 Groups Assessed by Fluid Balance
PO Intake
|
542 milliliters per day
Interval 0.0 to 2147.0
|
308 milliliters per day
Interval 0.0 to 1483.0
|
477 milliliters per day
Interval 13.0 to 743.0
|
|
Changes Between the 3 Groups Assessed by Fluid Balance
Urine Output
|
1921 milliliters per day
Interval 550.0 to 2483.0
|
1600 milliliters per day
Interval 276.0 to 2300.0
|
1100 milliliters per day
Interval 100.0 to 2250.0
|
SECONDARY outcome
Timeframe: post-op period, up until dischargeLength of hospitalization, recorded as median days
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Length of Hospitalization
|
4 days
Interval 1.0 to 11.0
|
2 days
Interval 1.0 to 12.0
|
2 days
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: post-op period, up until dischargeReturn to oral intake (PO) status, recorded in median days
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status
|
1 days
Interval 0.0 to 4.0
|
1 days
Interval 0.0 to 5.0
|
1 days
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure
SBP
|
-9.6 mmHg * hours
Interval -33.7 to 14.5
|
-5.0 mmHg * hours
Interval -8.6 to 18.7
|
-4.5 mmHg * hours
Interval -23.2 to 1421.0
|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure
DBP
|
-0.3 mmHg * hours
Interval -13.9 to 13.2
|
-6.1 mmHg * hours
Interval -17.1 to 5.0
|
-8.2 mmHg * hours
Interval -18.8 to 2.4
|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure
MAP
|
6.4 mmHg * hours
Interval -9.3 to 22.2
|
-6.4 mmHg * hours
Interval -21.0 to 8.1
|
-11.6 mmHg * hours
Interval -26.7 to 3.4
|
SECONDARY outcome
Timeframe: Measured at 12-hour intervals for first 48 hours postopoerativePain 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.
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Differences Between the 3 Groups Assessed by Pain
0-12 hours
|
3.5 units on a scale
Interval 2.4 to 4.7
|
2.5 units on a scale
Interval 1.4 to 3.7
|
4.3 units on a scale
Interval 3.2 to 5.5
|
|
Differences Between the 3 Groups Assessed by Pain
12-24 hours
|
4.4 units on a scale
Interval 2.9 to 5.8
|
3.9 units on a scale
Interval 2.5 to 5.3
|
3.9 units on a scale
Interval 2.3 to 5.5
|
|
Differences Between the 3 Groups Assessed by Pain
24-36 hours
|
4.3 units on a scale
Interval 2.9 to 5.8
|
4.3 units on a scale
Interval 3.0 to 5.6
|
3.5 units on a scale
Interval 2.3 to 4.7
|
|
Differences Between the 3 Groups Assessed by Pain
36-48 hours
|
3.0 units on a scale
Interval 1.5 to 4.6
|
3.7 units on a scale
Interval 2.2 to 5.1
|
3.6 units on a scale
Interval 2.4 to 4.9
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate
|
-10.2 breaths/min * hours
Interval -13.7 to 6.7
|
-4.2 breaths/min * hours
Interval -8.3 to 0.02
|
-3.6 breaths/min * hours
Interval -6.7 to -0.4
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate
|
17.3 beats/min * hours
Interval -33.5 to 22.2
|
-2.1 beats/min * hours
Interval -11.3 to 7.2
|
0.9 beats/min * hours
Interval -9.6 to 11.4
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Ropivacaine Only Control Group
n=15 Participants
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 Participants
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 Participants
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.
|
|---|---|---|---|
|
Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation
|
11.5 % saturation * hours
Interval -17.9 to 40.9
|
1.8 % saturation * hours
Interval -4.6 to 8.2
|
0.3 % saturation * hours
Interval -2.5 to 3.2
|
Adverse Events
Ropivacaine Only Control Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Ropivacaine + 2 mcg/mL Epinephrine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ropivacaine + 5 mcg/mL Epinephrine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ropivacaine Only Control Group
n=15 participants at risk
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.
|
Ropivacaine + 2 mcg/mL Epinephrine
n=16 participants at risk
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.
|
Ropivacaine + 5 mcg/mL Epinephrine
n=16 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.3%
2/15 • Adverse events were recording across postoperative period until dishcarge
|
31.2%
5/16 • Adverse events were recording across postoperative period until dishcarge
|
6.2%
1/16 • Adverse events were recording across postoperative period until dishcarge
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
33.3%
5/15 • Adverse events were recording across postoperative period until dishcarge
|
50.0%
8/16 • Adverse events were recording across postoperative period until dishcarge
|
56.2%
9/16 • Adverse events were recording across postoperative period until dishcarge
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Depression
|
80.0%
12/15 • Adverse events were recording across postoperative period until dishcarge
|
75.0%
12/16 • Adverse events were recording across postoperative period until dishcarge
|
87.5%
14/16 • Adverse events were recording across postoperative period until dishcarge
|
Additional Information
Dr. Terrie Vasilopoulos
University of Florida, College of Medicine
Phone: 3522738910
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place