Pain Clinical Trial
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
Verified date | February 2020 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 14, 2018 |
Est. primary completion date | October 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UF Health | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | I. Heermann Anesthesia Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline to end of the intra-operative period | |
Secondary | 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. | Change from baseline to 72 hours after discharge from the post anesthesia care unit (PACU) | |
Secondary | 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. | From post-operative (post-op) day 1 to post-op day 3 | |
Secondary | 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. | From day of surgery (0) to post-op day 3 | |
Secondary | 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. | From day of surgery (0) to post-op day 3 | |
Secondary | Changes between the 3 groups assessed by fluid balance | 24 hour intake and output for the first 72 hours to assess fluid balance | From post-op day 1 to post-op day 3 | |
Secondary | Changes between the 3 groups assessed by length of hospitalization | Length of hospitalization | From post-op day 1 to post-op day 3 | |
Secondary | Changes between the 3 groups assessed by amount of days before return to oral intake status | Return to oral intake status | From post-op day 1 to post-op day 3 |
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