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The Prevention of Hypotension After Epidural Analgesia After Major Surgery

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ClinicalTrials.gov Identifier: NCT02722746
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
I. Heermann Anesthesia Foundation
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Hypotension Pain Drug: Ropivacaine Drug: Epinephrine Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : October 4, 2017
Actual Study Completion Date : September 14, 2018


Arm Intervention/treatment
Placebo Comparator: Ropivacaine only Control group
The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure.
Drug: Ropivacaine
Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.
Other Name: Naropin

Active Comparator: Ropivacaine + 2 mcg/mL epinephrine
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure.
Drug: Ropivacaine
Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.
Other Name: Naropin

Drug: Epinephrine
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 Name: Adrenalin

Active Comparator: Ropivacaine + 5 mcg/mL epinephrine
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure.
Drug: Ropivacaine
Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.
Other Name: Naropin

Drug: Epinephrine
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 Name: Adrenalin




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. Changes between the 3 groups assessed by the spread of local anesthetic (block) effect [ Time Frame: Change from baseline to 72 hours after discharge from the post anesthesia care unit (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.

  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.

  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 to assess fluid balance

  6. Changes between the 3 groups assessed by length of hospitalization [ Time Frame: From post-op day 1 to post-op day 3 ]
    Length of hospitalization

  7. Changes between the 3 groups assessed by amount of days before return to oral intake status [ Time Frame: From post-op day 1 to post-op day 3 ]
    Return to oral intake status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722746


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
I. Heermann Anesthesia Foundation
Investigators
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Principal Investigator: Olga C. Nin, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02722746     History of Changes
Other Study ID Numbers: IRB201600185
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Epidural Analgesia

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Ropivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents