Erector Spinae Plane Block Catheters: The Role in Acute Postoperative Pain After Hepatic Resection With Intrathecal Morphine
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total opioid requirement postoperative day (POD) 1-3
研究概览
简要总结
To determine whether the addition of erector spinae plane (ESP) catheters to existing multimodal analgesic regimen with intrathecal morphine provides superior postoperative analgesia in patients undergoing hepatic resection compared with patients not receiving ESP catheters.
详细描述
Hepatic resection surgery is especially painful and requires optimal postoperative pain control for early mobilization and improved respiratory function. While there are many options for pain control, including IV opioids and thoracic epidurals, their utility is often limited by decreased metabolism and coagulopathy respectively. Our institution's current regimen including multimodal analgesia combined with intrathecal morphine and physician discretion with ESP catheters to facilitate postoperative pain management. However, the duration of intrathecal morphine is 24 hours, which is not cover the duration of significant post-operative leading to an increase in intravenous opioid consumption. ESP block is a paraspinal fascial plane between the erector spinae muscle and the thoracic transverse processes blocking the dorsal and ventral rami of the spinal nerves. This provides a multi-dermatomal sensory block of the anterior, posterior and lateral thoracic and abdominal walls. The addition of a catheter allows for a continuous infusion of local anesthetic. In addition, unlike a hepatic resection with a thoracic epidural coagulation status is not a concern. We believe that if patients' have improved post-operative pain control they will have better participation in physical therapy, require less opioids and potentially have shorter hospital length of stay.
Specific Aim: To determine if the addition of ESP catheters to multimodal pain regimen with intrathecal morphine, would provide superior postoperative analgesia beyond the morphine's twenty-four hour duration in patients undergoing hepatic resection compared to patients not receiving ESP catheters.
Hypothesis 1: Patients undergoing hepatic resection will have improved postoperative analgesia - based on mean opioid consumption and numeric rating scale pain scores - during postoperative day (POD) 1, as defined by 24 hours after intrathecal morphine, to POD 3 following surgery when receiving routine multimodal analgesia with intrathecal morphine and multimodal pain management with addition of ESP catheters versus multimodal analgesia with intrathecal morphine alone.
Hypothesis 2: Patients undergoing hepatic resection will have decreased incidence of persistent postoperative pain - based on mean opioid consumption and standard of care numeric rating scale pain scores during their hospital stay and at home- when receiving routine multimodal analgesia with intrathecal morphine with addition ESP catheters versus multimodal analgesia with intrathecal morphine alone.
This will be randomized, subject-masked, placebo-controlled, human subjects clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing hepatic resection
- •Admitting service requests APS consult
- •>18 years old and able to provide consent
- •Exclusion criteria:
- •pregnancy
- •incarceration
- •inability to communicate with the investigators and hospital staff
- •severe hepatic disease
- •chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
- •BMI > 40 kg/m2
- •allergy to study medications (lidocaine, ropivacaine)
排除标准
- 未提供
研究组 & 干预措施
Active Treatment
This group will receive a continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 120 minutes with 2ml/hr continuous infusion (14mls total every 2 hours per catheter)
干预措施: 0.2% ropivacaine local anesthetic continuous erector spinae plane block (Drug)
Active Treatment
This group will receive a continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 120 minutes with 2ml/hr continuous infusion (14mls total every 2 hours per catheter)
干预措施: Spinal Morphine (Drug)
Placebo
This group will receive a superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr
干预措施: 0.2% ropivacaine local anesthetic superficially taped continuous erector spinae plane block (Drug)
Placebo
This group will receive a superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr
干预措施: Spinal Morphine (Drug)
结局指标
主要结局
Total opioid requirement postoperative day (POD) 1-3
时间窗: Total use from post-operative day (POD) 1, as defined by 24 hours after intrathecal morphine, to POD 3 (3 days from admission to recovery unit)
Morphine Milligram Equivalents
次要结局
- Pain Score at rest and with cough(Post-Operative Day 0, 1, 2, 3, 4, 14, 30)
- Total opioid requirement postoperative day (POD) 0-4(Total use from hospital admission to POD 4 (4 days after admission to recovery unit))
- Discharge opioids and refills.(Typically within 14days of admission, then at 14 days, and at 30 days.)
- Nausea(Post-Operative Day 0, 1, 2, 3, 4)
- Time to ambulation(Post-Operative Day 0, 1, 2, 3, 4)
- Time to oral intake(Post-Operative Day 0, 1, 2, 3, 4)
- Hospital Length Of Stay(Total number of days requiring hospitalization for surgical procedure. Up to 1 month.)
研究者
Engy T. Said, MD
Associate Clinical Professor, Anesthesiology.
University of California, San Diego