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).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
20 ml
40 mL
Indiana Univeristy
Indianapolis, Indiana, United States
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
Time frame: 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
Time frame: Pain scores will be measured 72 hours after surgery
Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose
Opioid consumption will be collected by a study team member post operatively at hour 1 per protocol time requirements
Time frame: Opioid comsumption will be measured at 1 hour
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose
Opioid consumption will be collected by a study team member post operatively at hour 24 per protocol time requirements
Time frame: Opioid comsumption will be measured at 24 hours
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose
Opioid consumption will be collected by a study team member post operatively at hour 48 per protocol time requirements
Time frame: Opioid comsumption will be measured at 48 hours
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose
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60 mL
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
40 mL
Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements
Time frame: Opioid comsumption will be measured at 72 hours
Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose
Opioid consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pain scores will be measured 96 hours after surgery
Number of Participants With Nausea at 1 Hour
Nausea scores will be collected by study team member post operatively at hour 1 per protocol. Result is reported as nausea or no nausea.
Time frame: 1 hour
Number of Participants With Nausea at 24 Hours
Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Result is reported as nausea or no nausea.
Time frame: 24 hour
Number of Participants With Nausea at 48 Hours
Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Result is reported as nausea or no nausea.
Time frame: 48 hour
Number of Participants With Nausea at 72 Hours
Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Result is reported as nausea or no nausea.
Time frame: 72 hour
Number of Participants With Nausea at 96 Hours
Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Result is reported as nausea or no nausea.
Time frame: 96 hour
Number of Participants With Sedation at 1 Hour
Sedation scores will be collected by a study team member post operatively at hour 1. Results are interpreted as patient with or without any sedation.
Time frame: 1 hour
Number of Participants With Sedation at 24 Hours
Sedation scores will be collected by a study team member post operatively at hour 24. Results are interpreted as patient with or without any sedation.
Time frame: 24 hour
Number of Participants With Sedation at 48 Hours
Sedation scores will be collected by a study team member post operatively at hour 48. Results are interpreted as patient with or without any sedation.
Time frame: 48 hour
Number of Participants With Sedation at 72 Hours
Sedation scores will be collected by a study team member post operatively at hour 72. Results are interpreted as patient with or without any sedation.
Time frame: 72 hour
Number of Participants With Sedation at 96 Hours
Sedation scores will be collected by a study team member post operatively at hour 96. Results are interpreted as patient with or without any sedation.
Time frame: 96 hour
First Flatus-bowel Movement
The first time the patients passes gas post operatively.
Time frame: Assess daily until patient passes gas postoperatively, up to 120 hours after surgery
Postoperative Creatinine
Lab level of Creatinine will be recorded for 4 days post operatively.
Time frame: Creatinine level will be collected daily postoperatively for 4 days
Time to Discharge-Length of Stay
Length of Stay will be collected from Cerner Electronic Medical Record. Pt. followed for length of stay, up till 4 weeks after surgery.
Time frame: From hospital admission to discharge time
Incidence of Hypotension
Defined as BP decrease of more than 20% from baseline. The reported number for each arm is the cumulative number of hypotension episodes experienced in each arm.
Time frame: number of times hypotension occurred the first 96 hours after surgery.
Incidence of Respiratory Depression
Define by use of Narcan
Time frame: assess daily as yes/no up to 96hr
Ambulation Activity Postoperatively
Number of participants who got out of bed and is ambulatory on Postoperative Day 1 and postoperative Day 2
Time frame: Patients followed for ambulation activities on postop Day 1 and Day 2