The Prevention of Hypotension After Epidural Analgesia After Major Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2018-09-14

Brief Summary

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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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Detailed Description

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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

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Hypotension Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Epinephrine

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Epinephrine

Intervention Type 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.

Interventions

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Ropivacaine

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Naropin Adrenalin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No