Clinical trial NCT02722746: The Prevention of Hypotension After Epidural Analgesia After Major Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypotension
Pain
Keywords: Epidural Analgesia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: I. Heermann Anesthesia Foundation
First posted: 2016-03-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)

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

Primary outcomes:
measure: Changes Between the 3 Groups Assessed by Blood Pressure Measurement
timeFrame: Change from baseline to end of the intra-operative period
Secondary outcomes:
measure: Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect
timeFrame: Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU)
measure: Changes Between the 3 Groups Assessed by Ambulation After Surgery
timeFrame: From post-operative (post-op) day 1 to post-op day 3
measure: Changes Between the 3 Groups Assessed by Opioid Usage
timeFrame: From day of surgery (0) to post-op day 3
measure: Changes Between the 3 Groups Assessed by Opioid-related Side Effects
timeFrame: From day of surgery (0) to post-op day 3
measure: Changes Between the 3 Groups Assessed by Fluid Balance
timeFrame: From post-op day 1 to post-op day 3
measure: Changes Between the 3 Groups Assessed by Length of Hospitalization
timeFrame: post-op period, up until discharge
measure: Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status
timeFrame: post-op period, up until discharge
measure: Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure
timeFrame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
measure: Differences Between the 3 Groups Assessed by Pain
timeFrame: Measured at 12-hour intervals for first 48 hours postopoerative
measure: Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate
timeFrame: Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
measure: Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate
timeFrame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
measure: Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation
timeFrame: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Olga C. Nin, MD
role: PRINCIPAL_INVESTIGATOR
References: