The Prevention of Hypotension After Epidural Analgesia After Major Surgery

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University of Florida

Status

Completed

Conditions

Hypotension
Pain

Treatments

Drug: Epinephrine
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02722746
IRB201600185

Details and patient eligibility

About

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.

Full 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: 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)

Enrollment

66 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

66 participants in 3 patient groups, including a placebo group

Ropivacaine only Control group
Placebo Comparator group
Description:
The participants in this group will receive standard anesthesia, epidural analgesia with 0.2% ropivacaine with no epinephrine added during the procedure.
Treatment:
Drug: Ropivacaine
Ropivacaine + 2 mcg/mL epinephrine
Active Comparator group
Description:
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 2mcg/mL of epinephrine during the procedure.
Treatment:
Drug: Ropivacaine
Drug: Epinephrine
Ropivacaine + 5 mcg/mL epinephrine
Active Comparator group
Description:
The participants in this group will receive standard anesthesia (Ropivacaine 0.2%) with the addition of 5mcg/mL of epinephrine during the procedure.
Treatment:
Drug: Ropivacaine
Drug: Epinephrine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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