Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- VAS Score at 48 Hour
研究概览
简要总结
The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).
详细描述
The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder). By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (feeling sick to your stomach, feeling drowsy/sleepy, blockage/lack of movement in the intestines, inability to completely empty the bladder, unusually slow or shallow breathing).
The specific aim of this study is to compare the difference between the pain control methods in achieving the following:
- Decreased opioid requirements
- Improved postoperative VAS pain scores
- Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression)
- Decreased hospital length of stay (LOS)
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
- None
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
- •Patients undergoing cystectomy for bladder cancer
- •ASA class 1, 2, 3 or 4
- •Age 18 or older, male or female
- •Desires Regional anesthesia for postoperative pain control
排除标准
- •Any contraindication for thoracic epidural.
- •History of substance abuse in the past 6 months.
- •Patients on more than 30mg morphine equivalents of opioids daily.
- •Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
- •Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine, Hydromorphone).
- •Postoperative intubation.
- •Any patient with history of neuropathic bowel or bladder dysfunction
研究组 & 干预措施
Thoracic epidural
- Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
干预措施: epidural bupivacaine 0.05% (Drug)
Thoracic epidural
- Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
干预措施: /hydromorphone 0.05mg/ml (Drug)
Rectus Sheath Block
- Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
干预措施: Liposomal bupivacaine (Drug)
Rectus Sheath Block
- Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
干预措施: bupivacaine 0.125% (Drug)
Rectus Sheath Block
- Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.
干预措施: injectable saline (Drug)
Surgeon Infiltration with Liposomal Bupivacaine (LB)
- Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
干预措施: Liposomal bupivacaine (Drug)
Surgeon Infiltration with Liposomal Bupivacaine (LB)
- Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
干预措施: bupivacaine 0.125% (Drug)
Surgeon Infiltration with Liposomal Bupivacaine (LB)
- Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.
干预措施: injectable saline (Drug)
Surgeon Infiltration
- Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
干预措施: bupivacaine 0.5% (Drug)
Surgeon Infiltration
- Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.
干预措施: injectable saline (Drug)
结局指标
主要结局
VAS Score at 48 Hour
时间窗: Pain scores will be measured 48 hours after surgery
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
VAS Score at 72 Hour
时间窗: Pain scores will be measured 72 hours after surgery
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
次要结局
- Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose(Opioid comsumption will be measured at 48 hours)
- Number of Participants With Sedation at 1 Hour(1 hour)
- VAS Score at 1 Hour(Pain scores will be measured 1 hour after surgery)
- Number of Participants With Sedation at 48 Hours(48 hour)
- Number of Participants With Nausea at 72 Hours(72 hour)
- Number of Participants With Nausea at 96 Hours(96 hour)
- Time to Discharge-Length of Stay(From hospital admission to discharge time)
- Incidence of Hypotension(number of times hypotension occurred the first 96 hours after surgery.)
- Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose(Opioid comsumption will be measured at 1 hour)
- Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose(Opioid comsumption will be measured at 24 hours)
- Number of Participants With Nausea at 1 Hour(1 hour)
- Number of Participants With Nausea at 48 Hours(48 hour)
- Number of Participants With Sedation at 96 Hours(96 hour)
- Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose(Opioid comsumption will be measured at 72 hours)
- Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose(Opioid comsumption will be measured at 96 hours)
- VAS Score at 24(Pain scores will be measured 24 hours after surgery)
- VAS Score at 96 Hour(Pain scores will be measured 96 hours after surgery)
- Number of Participants With Nausea at 24 Hours(24 hour)
- Number of Participants With Sedation at 24 Hours(24 hour)
- Number of Participants With Sedation at 72 Hours(72 hour)
- First Flatus-bowel Movement(Assess daily until patient passes gas postoperatively, up to 120 hours after surgery)
- Incidence of Respiratory Depression(assess daily as yes/no up to 96hr)
- Postoperative Creatinine(Creatinine level will be collected daily postoperatively for 4 days)
- Ambulation Activity Postoperatively(Patients followed for ambulation activities on postop Day 1 and Day 2)
研究者
Yar Yeap
Director, Acute Pain Service, Assistant Professor of Clinical Anesthesiology, Dept of Anesthesiology
Indiana University