The Prevention of Hypotension After Epidural Analgesia After Major Surgery
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/16/2019 |
| Start Date: | November 15, 2016 |
| End Date: | September 14, 2018 |
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.
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.
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)
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)
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
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