Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

Conditions
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Cystectomy

Intervention / Treatment
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* Drug: epidural bupivacaine 0.05%
* Drug: Liposomal bupivacaine
* Drug: bupivacaine 0.125%
* Drug: bupivacaine 0.5%
* Drug: /hydromorphone 0.05mg/ml
* Drug: injectable saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Thoracic Epidural Analgesia Rectus Sheath Block Surgeon Infiltration with Liposomal Bupivacaine Standard Bupivacaine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic epidural<br>1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia. | Drug: epidural bupivacaine 0.05%<br>* Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.<br>Drug: /hydromorphone 0.05mg/ml<br>* Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.<br>|
| Active Comparator: Rectus Sheath Block<br>2. 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. | Drug: Liposomal bupivacaine<br>* 20 ml<br>Drug: bupivacaine 0.125%<br>* 40 mL<br>Drug: injectable saline<br>* 40 mL<br>|
| Active Comparator: Surgeon Infiltration with Liposomal Bupivacaine (LB)<br>3. 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. | Drug: Liposomal bupivacaine<br>* 20 ml<br>Drug: bupivacaine 0.125%<br>* 40 mL<br>Drug: injectable saline<br>* 40 mL<br>|
| Active Comparator: Surgeon Infiltration<br>4. 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. | Drug: bupivacaine 0.5%<br>* 60 mL<br>Drug: injectable saline<br>* 40 mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score at 48 hour | 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 | Pain scores will be measured 48 hours after surgery | 
| VAS score at 72 hour | 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 | Pain scores will be measured 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint includes total opioid consumption at 1 hour | Opioid consumption will be collected by a study team member post operatively at hour 1 per protocol time requirements | Opioid comsumption will be measured at 1 hour | 
| Secondary endpoint includes total opioid consumption at 24 hours | Opioid consumption will be collected by a study team member post operatively at hour 24 per protocol time requirements | Opioid comsumption will be measured at 24 hours | 
| Secondary endpoint includes total opioid consumption at 48 hours | Opioid consumption will be collected by a study team member post operatively at hour 48 per protocol time requirements | Opioid comsumption will be measured at 48 hours | 
| Secondary endpoint includes total opioid consumption at 72 hours | Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements | Opioid comsumption will be measured at 72 hours | 
| Secondary endpoint includes total opioid consumption at 96 hours | Opioid consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements | Opioid comsumption will be measured at 96 hours | 
| VAS score at 1 hour | 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 | Pain scores will be measured 1 hour after surgery | 
| VAS score at 24 | 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 | Pain scores will be measured 24 hours after surgery | 
| VAS score at 96 hour | 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 | Pain scores will be measured 96 hours after surgery | 
| Average Nausea score 1 hour | Nausea scores will be collected by study team member post operatively at hour 1 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3). | 1 hour | 
| Average Nausea score 24 hour | Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3). | 24 hour | 
| Average Nausea score 48 hour | Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3). | 48 hour | 
| Average Nausea score 72 hour | Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3). | 72 hour | 
| Average Nausea score 96 hour | Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3). | 96 hour | 
| Average Sedation score at 1 hour | Sedation scores will be collected by a study team member post operatively at hour 1 per protocol requirements. Determining if patient is awake & alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome. | 1 hour | 
| Average Sedation score at 24 hour | Sedation scores will be collected by a study team member post operatively at hour 24 per protocol requirements. Determining if patient is awake & alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome. | 24 hour | 
| Average Sedation score at 48 hour | Sedation scores will be collected by a study team member post operatively at hour 48 per protocol requirements. Determining if patient is awake & alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher scores mean a worse outcome. | 48 hour | 
| Average Sedation score at 72 hour | Sedation scores will be collected by a study team member post operatively at hour 72 per protocol requirements. Determining if patient is awake & alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome. | 72 hour | 
| Average Sedation score at 96 hour | Sedation scores will be collected by a study team member post operatively at hour 96 per protocol requirements. Determining if patient is awake & alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome. | 96 hour | 
| First Flatus-bowel movement | The passing of gas will be collected by a study team member as per protocol requirements. This is only for the first time the patients passes gas post operatively and is expected to occur during the hospital admission prior to patients discharge. The outcome measure will be assessed through study completion, an average of 1week. | Assess daily until patient passes gas postoperatively within 72 hours | 
| Incidence of Urinary Retention-Postoperative Creatinine | Lab level of Creatinine will be collected if only ordered by the surgeon doing the surgery. I will be recorded or documented for 4 days post operatively. | Creatinine level will be collected daily postoperatively for 4 days | 
| Time to Discharge-Length of Stay | LOS will be collected via EMR | From hospital admission to discharge date up to 3weeks | 
| Incidence of Hypotension | Defined as BP decrease of more than 20% from baseline | daily during 96 hour assessment period | 
| Incidence of Respiratory Depression | Define by use of Narcan | assess daily as yes/no | 
| Ambulation Activity | Define as anytime out of bed: up in chair, to bathroom or walking hall with PT/nurse | will be recorded daily as yes/no |