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NCT Number: NCT02722746

The Prevention of Hypotension After Epidural Analgesia After Major Surgery

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UF Health

Gainesville, Florida, 32610, United States

About this study

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:

  • Group A (Ropivacaine 0.2% infusion; Control group)
  • Group B (Ropivacaine 0.2% + 2 mcg/mL epinephrine)
  • Group C (Ropivacaine 0.2% + 5 mcg/mL epinephrine)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Other names: Naropin

Epinephrine

Drug

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.

Other names: Adrenalin

Primary outcomes

  1. Changes Between the 3 Groups Assessed by Blood Pressure Measurement

    Time frame: 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 outcomes

  1. Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect

    Time frame: 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.

  2. Changes Between the 3 Groups Assessed by Ambulation After Surgery

    Time frame: 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

  3. Changes Between the 3 Groups Assessed by Opioid Usage

    Time frame: 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.

  4. Changes Between the 3 Groups Assessed by Opioid-related Side Effects

    Time frame: 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.

  5. Changes Between the 3 Groups Assessed by Fluid Balance

    Time frame: 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).

  6. Changes Between the 3 Groups Assessed by Length of Hospitalization

    Time frame: post-op period, up until discharge

    Length of hospitalization, recorded as median days

  7. Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status

    Time frame: post-op period, up until discharge

    Return to oral intake (PO) status, recorded in median days

  8. Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure

    Time frame: 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

  9. Differences Between the 3 Groups Assessed by Pain

    Time frame: 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.

  10. Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate

    Time frame: 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

  11. Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate

    Time frame: 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

  12. Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • I. Heermann Anesthesia Foundation

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 30, 2016
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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