Phase 2
N=66
The Prevention of Hypotension After Epidural Analgesia After Major Surgery
Hypotension · Pain
Bottom Line
View on ClinicalTrials.gov: NCT02722746 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Changes Between the 3 Groups Assessed by Blood Pressure Measurement — 5; 2; 3; 10 Participants — p=0.165
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ropivacaine (Drug); Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes Between the 3 Groups Assessed by Blood Pressure Measurement |
5; 2; 3; 10; 14; 13 | 0.165 |
| SECONDARY Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect |
8; 11; 9; 10; 9; 7 | 0.06 |
| SECONDARY Changes Between the 3 Groups Assessed by Ambulation After Surgery |
125.5; 90.2; 139.1 | 0.551 |
| SECONDARY Changes Between the 3 Groups Assessed by Opioid Usage |
27.2; 40.4; 14.9; 41.9; 65.1; 28.3 | 0.349 |
| SECONDARY Changes Between the 3 Groups Assessed by Opioid-related Side Effects |
1; 5; 1; 5; 8; 9 | 0.18 |
| SECONDARY Changes Between the 3 Groups Assessed by Fluid Balance |
164; 305; 315; 2428; 1300; 1843 | — |
| SECONDARY Changes Between the 3 Groups Assessed by Length of Hospitalization |
4; 2; 2 | — |
| SECONDARY Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status |
1; 1; 1 | — |
| SECONDARY Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure |
-9.6; -5.0; -4.5; -0.3; -6.1; -8.2 | 0.524 |
| SECONDARY Differences Between the 3 Groups Assessed by Pain |
3.5; 2.5; 4.3; 4.4; 3.9; 3.9 | 0.231 |
| SECONDARY Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate |
-10.2; -4.2; -3.6 | 0.016 sig |
| SECONDARY Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate |
17.3; -2.1; 0.9 | 0.055 |
| SECONDARY Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation |
11.5; 1.8; 0.3 | 0.567 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02722746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.