The Prevention of Hypotension After Epidural Analgesia After Major Surgery
Condition: Hypotension; Pain
MeSH terms: Hypotension
Study type: Interventional

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)
    

Intervention name(s): Ropivacaine; Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.; 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 intervention name(s): Naropin; Adrenalin
Intervention MeSH terms: Epinephrine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Epidural Analgesia