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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Changes Between the 3 Groups Assessed by Blood Pressure Measurement
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing epidural analgesia to treat perioperative pain associated with major surgery
- •undergoing major thoracic surgery
- •undergoing major abdominal surgery
- •undergoing major orthopaedic surgery
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Ropivacaine (Drug)
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.
干预措施: Ropivacaine (Drug)
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.
干预措施: Epinephrine (Drug)
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.
干预措施: Ropivacaine (Drug)
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.
干预措施: Epinephrine (Drug)
结局指标
主要结局
Changes Between the 3 Groups Assessed by Blood Pressure Measurement
时间窗: Change from baseline to end of the intra-operative period
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.
次要结局
- Changes Between the 3 Groups Assessed by the Spread of Local Anesthetic (Block) Effect(Preop, post anesthesia care unit (PACU), Post-op Da 1 (POD 1, 72 hours after discharge from PACU))
- Changes Between the 3 Groups Assessed by Ambulation After Surgery(From post-operative (post-op) day 1 to post-op day 3)
- Changes Between the 3 Groups Assessed by Opioid Usage(From day of surgery (0) to post-op day 3)
- Changes Between the 3 Groups Assessed by Opioid-related Side Effects(From day of surgery (0) to post-op day 3)
- Changes Between the 3 Groups Assessed by Fluid Balance(From post-op day 1 to post-op day 3)
- Changes Between the 3 Groups Assessed by Length of Hospitalization(post-op period, up until discharge)
- Changes Between the 3 Groups Assessed by Days to Return to Oral Intake Status(post-op period, up until discharge)
- Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Blood Pressure(Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours))
- Differences Between the 3 Groups Assessed by Pain(Measured at 12-hour intervals for first 48 hours postopoerative)
- Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Respiratory Rate(Change from preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours))
- Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Heart Rate(Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours))
- Changes Between the 3 Groups Continously Measured Cardiovascular Outcomes - Oxygen Saturation(Change across preoperative, intraoperative, Post Anesthesia Care Unit (PACU), and transfer to floor (up to 72 hours))