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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic epidural | Active Comparator | 1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia. |
|
| Rectus Sheath Block | Active Comparator | 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. |
|
| Surgeon Infiltration with Liposomal Bupivacaine (LB) | Active Comparator | 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. |
|
| Surgeon Infiltration | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epidural bupivacaine 0.05% | Drug | Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Opioid comsumption will be measured at 1 hour |
| Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yar Yeap, MD | Indiana University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana Univeristy | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Butterworth Iv, John F., David C. Mackey, and John D. Wasnick. | ||
| Background | de Boer, H. D., O. Detriche, and P. Forget. | ||
| Background | Guo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma. | ||
| Background | Hou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li. | ||
| Background | Kalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al. | ||
| 18595236 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thoracic Epidural | 1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia. epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. /hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2019 |
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| Liposomal bupivacaine | Drug | 20 ml |
|
| bupivacaine 0.125% | Drug | 40 mL |
|
| bupivacaine 0.5% | Drug | 60 mL |
|
| /hydromorphone 0.05mg/ml | Drug | Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. |
|
| injectable saline | Drug | 40 mL |
|
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 PO Morphine Equivalent Dose | 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 PO Morphine Equivalent Dose | 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 PO Morphine Equivalent Dose | 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 96 hour |
| First Flatus-bowel Movement | The first time the patients passes gas post operatively. | 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. | 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. | 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. | number of times hypotension occurred the first 96 hours after surgery. |
| Incidence of Respiratory Depression | Define by use of Narcan | 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 | Patients followed for ambulation activities on postop Day 1 and Day 2 |
| Background |
| Ladjevic N, Likic-Ladjevic I, Dzamic Z, Acimovic M, Dragicevic D, Durutovic O. Combined general and epidural anaesthesia versus general anaesthesia for radical cystectomy. Acta Chir Iugosl. 2007;54(4):89-91. doi: 10.2298/aci0704089l. |
| 25509242 | Background | Mazul-Sunko B, Gilja I, Jelisavac M, Kozul I, Troha D, Osmancevic N, El-Saleh A, Markic A, Kovacevic M, Bokarica P. Thoracic epidural analgesia for radical cystectomy improves bowel function even in traditional perioperative care: a retrospective study in eighty-five patients. Acta Clin Croat. 2014 Sep;53(3):319-25. |
| 15711112 | Background | Ozyuvaci E, Altan A, Karadeniz T, Topsakal M, Besisik A, Yucel M. General anesthesia versus epidural and general anesthesia in radical cystectomy. Urol Int. 2005;74(1):62-7. doi: 10.1159/000082712. |
| Background | ozek, J. J., M. De Ruyter, and T. W. Khan. |
| Background | Sun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al. |
| FG001 | Rectus Sheath Block | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL |
| FG002 | Surgeon Infiltration With Liposomal Bupivacaine (LB) | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL |
| FG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Thoracic Epidural | 1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia. epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. /hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. |
| BG001 | Rectus Sheath Block | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL |
| BG002 | Surgeon Infiltration With Liposomal Bupivacaine (LB) | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL |
| BG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (BMI) inkg/m^2 | Mean | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Duration of Surgery-in minutes | Median | Inter-Quartile Range | minutes |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 48-hour Pain Scores | Posted | Median | Full Range | score on a scale | Pain scores will be measured 48 hours after surgery |
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| Primary | 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 at 72 hour | Posted | Mean | Full Range | score on a scale | Pain scores will be measured 72 hours after surgery |
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| Secondary | 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 | 1-hour opioid consumption | Posted | Mean | Inter-Quartile Range | milligram morphine equivalents | Opioid comsumption will be measured at 1 hour |
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| Secondary | 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 | Opioid consumption at 24-hour | Posted | Mean | Inter-Quartile Range | milligram morphine equivalents | Opioid comsumption will be measured at 24 hours |
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| Secondary | 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 | Opioid consumption at 48 hour | Posted | Mean | Inter-Quartile Range | milligram morphine equivalents | Opioid comsumption will be measured at 48 hours |
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| Secondary | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements | Opioid consumption at 72 hour | Posted | Mean | Inter-Quartile Range | milligram morphine equivalents | Opioid comsumption will be measured at 72 hours |
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| Secondary | 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 | Opioid consumption at 96 hour | Posted | Mean | Inter-Quartile Range | milligram morphine equivalents | Opioid comsumption will be measured at 96 hours |
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| Secondary | 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 | 1-hour pain scores | Posted | Mean | Full Range | score on a scale | Pain scores will be measured 1 hour after surgery |
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| Secondary | 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 | 24-hour Pain Scores | Posted | Mean | Inter-Quartile Range | score on a scale | Pain scores will be measured 24 hours after surgery |
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| Secondary | 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 | 96-hour pain scores | Posted | Mean | Inter-Quartile Range | score on a scale | Pain scores will be measured 96 hours after surgery |
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| Secondary | 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. | 1-hour nausea score | Posted | Number | participants | 1 hour |
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| Secondary | 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. | 24-hour nausea score | Posted | Number | participants | 24 hour |
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| Secondary | 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. | 48-hour nausea score | Posted | Number | participants | 48 hour |
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| Secondary | 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. | 72-hour nausea score | Posted | Number | participants | 72 hour |
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| Secondary | 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. | 96-hour nausea score | Posted | Number | participants | 96 hour |
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| Secondary | 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. | 1hr sedation score | Posted | Number | participants | 1 hour |
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| Secondary | 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. | 24-hour sedation score | Posted | Number | participants | 24 hour |
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| Secondary | 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. | 48-hour sedation score | Posted | Number | participants | 48 hour |
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| Secondary | 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. | 72-hour sedation score | Posted | Number | participants | 72 hour |
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| Secondary | 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. | 96-hour sedation score | Posted | Number | participants | 96 hour |
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| Secondary | First Flatus-bowel Movement | The first time the patients passes gas post operatively. | Time to first Flatus | Posted | Mean | Inter-Quartile Range | Hours | Assess daily until patient passes gas postoperatively, up to 120 hours after surgery |
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| Secondary | Postoperative Creatinine | Lab level of Creatinine will be recorded for 4 days post operatively. | creatinine level Postoperatively | Posted | Mean | Inter-Quartile Range | mg/dL | Creatinine level will be collected daily postoperatively for 4 days |
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| Secondary | 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. | Length of Stay (LOS) | Posted | Mean | Inter-Quartile Range | days | From hospital admission to discharge time |
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| Secondary | 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. | cumulative number of hypotension episodes in 96 hours | Posted | Number | hypotension episodes | number of times hypotension occurred the first 96 hours after surgery. |
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| Secondary | Incidence of Respiratory Depression | Define by use of Narcan | Incidence of Respiratory Depression | Posted | Count of Participants | Participants | assess daily as yes/no up to 96hr |
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| Secondary | Ambulation Activity Postoperatively | Number of participants who got out of bed and is ambulatory on Postoperative Day 1 and postoperative Day 2 | Ambulation activity | Posted | Count of Participants | Participants | Patients followed for ambulation activities on postop Day 1 and Day 2 |
|
Adverse events were collected for up to 3 weeks of hospitalization stay
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thoracic Epidural | 1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia. epidural bupivacaine 0.05%: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. /hydromorphone 0.05mg/ml: Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG001 | Rectus Sheath Block | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL | 0 | 40 | 0 | 40 | 4 | 40 |
| EG002 | Surgeon Infiltration With Liposomal Bupivacaine (LB) | 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. Liposomal bupivacaine: 20 ml bupivacaine 0.125%: 40 mL injectable saline: 40 mL | 0 | 40 | 0 | 40 | 8 | 40 |
| EG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL | 0 | 40 | 0 | 40 | 2 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| respiratory depression | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | defined as narcan used for respiratory depression |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yar Luan Yeap, MD | Indiana University Department of Anesthesiology | 317-274-0275 | yyeap@iupui.edu |
| Apr 17, 2024 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| 48-hour Pain Scores at Rest |
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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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.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
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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.
Liposomal bupivacaine: 20 ml
bupivacaine 0.125%: 40 mL
injectable saline: 40 mL
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
|
| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
|
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| OG003 | Surgeon Infiltration | 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. bupivacaine 0.5%: 60 mL injectable saline: 40 mL |
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