Clinical trial NCT04300231: Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Official title: Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystectomy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Thoracic Epidural Analgesia
2. Rectus Sheath Block
3. Surgeon Infiltration with Liposomal Bupivacaine
4. Standard Bupivacaine
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. Decreased opioid requirements
2. Improved postoperative VAS pain scores
3. Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression)
4. Decreased hospital length of stay (LOS)

Eligibility criteria: 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

Primary outcomes:
measure: VAS Score at 48 Hour
timeFrame: Pain scores will be measured 48 hours after surgery
measure: VAS Score at 72 Hour
timeFrame: Pain scores will be measured 72 hours after surgery
Secondary outcomes:
measure: Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose
timeFrame: Opioid comsumption will be measured at 1 hour
measure: Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose
timeFrame: Opioid comsumption will be measured at 24 hours
measure: Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose
timeFrame: Opioid comsumption will be measured at 48 hours
measure: Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose
timeFrame: Opioid comsumption will be measured at 72 hours
measure: Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose
timeFrame: Opioid comsumption will be measured at 96 hours
measure: VAS Score at 1 Hour
timeFrame: Pain scores will be measured 1 hour after surgery
measure: VAS Score at 24
timeFrame: Pain scores will be measured 24 hours after surgery
measure: VAS Score at 96 Hour
timeFrame: Pain scores will be measured 96 hours after surgery
measure: Number of Participants With Nausea at 1 Hour
timeFrame: 1 hour
measure: Number of Participants With Nausea at 24 Hours
timeFrame: 24 hour
measure: Number of Participants With Nausea at 48 Hours
timeFrame: 48 hour
measure: Number of Participants With Nausea at 72 Hours
timeFrame: 72 hour
measure: Number of Participants With Nausea at 96 Hours
timeFrame: 96 hour
measure: Number of Participants With Sedation at 1 Hour
timeFrame: 1 hour
measure: Number of Participants With Sedation at 24 Hours
timeFrame: 24 hour
measure: Number of Participants With Sedation at 48 Hours
timeFrame: 48 hour
measure: Number of Participants With Sedation at 72 Hours
timeFrame: 72 hour
measure: Number of Participants With Sedation at 96 Hours
timeFrame: 96 hour
measure: First Flatus-bowel Movement
timeFrame: Assess daily until patient passes gas postoperatively, up to 120 hours after surgery
measure: Postoperative Creatinine
timeFrame: Creatinine level will be collected daily postoperatively for 4 days
measure: Time to Discharge-Length of Stay
timeFrame: From hospital admission to discharge time
measure: Incidence of Hypotension
timeFrame: number of times hypotension occurred the first 96 hours after surgery.
measure: Incidence of Respiratory Depression
timeFrame: assess daily as yes/no up to 96hr
measure: Ambulation Activity Postoperatively
timeFrame: Patients followed for ambulation activities on postop Day 1 and Day 2
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Univeristy
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: Yar Yeap, MD
role: PRINCIPAL_INVESTIGATOR
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