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HypotensionPhase 1/2NCT02722746

The Prevention of Hypotension After Epidural Analgesia After Major Surgery

A Phase 1/2 study testing Ropivacaine and Epinephrine in people with Hypotension and Pain, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypotension, Pain
What is being tested?
Ropivacaine and Epinephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteUnited States
Study dates
15 Nov 2016to 14 Sep 2018
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • undergoing epidural analgesia to treat perioperative pain associated with major surgery
  • undergoing major thoracic surgery
  • undergoing major abdominal surgery
  • undergoing major orthopaedic surgery

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UF Health

    Gainesville, Florida, 32610

Other trials in United States

About this study

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

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.

Read the 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)
Conditions
Hypotension, Pain
Being tested
Ropivacaine, Epinephrine
Keywords
Epidural Analgesia
Medical subject headings
Hypotension, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called Naropin

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

  • EpinephrineDrug

    Also called Adrenalin

    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.

Study groups in NCT02722746
Study groupRoleWhat they receive
Ropivacaine only Control groupPlacebo comparatorThe participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure.
Receives: Drug: Ropivacaine
Ropivacaine + 2 mcg/mL epinephrineActive comparatorThe participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure.
Receives: Drug: Ropivacaine; Drug: Epinephrine
Ropivacaine + 5 mcg/mL epinephrineActive comparatorThe participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure.
Receives: Drug: Ropivacaine; Drug: Epinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Change from baseline to end of the intra-operative period

Secondary outcomes (12)

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

    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.

    Measured: Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU)

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

    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

    Measured: From post-operative (post-op) day 1 to post-op day 3

  3. Changes Between the 3 Groups Assessed by Opioid Usage

    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.

    Measured: From day of surgery (0) to post-op day 3

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

    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.

    Measured: From day of surgery (0) to post-op day 3

  5. Changes Between the 3 Groups Assessed by Fluid Balance

    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).

    Measured: From post-op day 1 to post-op day 3

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

    Length of hospitalization, recorded as median days

    Measured: post-op period, up until discharge

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

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

    Measured: post-op period, up until discharge

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

    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

    Measured: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)

  9. Differences Between the 3 Groups Assessed by Pain

    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.

    Measured: Measured at 12-hour intervals for first 48 hours postopoerative

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

    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

    Measured: Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)

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

    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

    Measured: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)

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

    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

    Measured: Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion4 Oct 2017
  4. Study completion14 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722746
Sponsor's protocol ID
IRB201600185
Status last verified
Jun 2025
First submitted
23 Mar 2016
Last updated
18 Jun 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nin OC, Boezaart A, Giordano C, Hughes SJ, Parvataneni HK, Reina MA, Schirmer A, Vasilopoulos T. Pilot epinephrine dose-finding study to counter epidural-related blood pressure reduction. Reg Anesth Pain Med. 2025 Nov 5;50(11):901-906. doi: 10.1136/rapm-2024-105406.

    PubMed 38991714

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ropivacaine and Epinephrine in people with Hypotension and Pain, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes Between the 3 Groups Assessed by Blood Pressure Measurement (time frame: Change from baseline to end of the intra-operative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02722746, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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