CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Ropivacaine +1 moredrug
Likely dose
Ropivacaine 0.2% epidural infusion with epinephrine (dose-finding study)AI-extracted
Key inclusion· 4
  • Undergoing epidural analgesia for perioperative pain management associated with major surgery
  • Undergoing major thoracic surgery
  • Undergoing major abdominal surgery
  • Undergoing major orthopaedic surgery
Key exclusion· 8
  • Sepsis
  • Acute trauma
  • Coagulopathy
  • Preoperative hemodynamic instability

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02722746
NCT02722746Phase 2Completed

The Prevention of Hypotension After Epidural Analgesia After Major Surgery by Adding Epinephrine to Infusions to Counteract Sympathectomy: a Double- Blind, Controlled, Randomized, Prospective Dose-finding Study

University of Florida·interventional·Posted Mar 30, 2016·Updated Jun 18, 2025

In Brief

A Phase 2 clinical trial evaluating Ropivacaine and Epinephrine for Hypotension and Pain. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypotension, Pain
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 30, 2016
Enrollment StartNov 15, 2016
Primary CompletionOct 4, 2017
Study CompletionSep 14, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.3 years ago

Interventions

Ropivacainedrug

Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.

Epinephrinedrug

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.