Cystectomy
Conditions
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)
Interventions
DRUGepidural bupivacaine 0.05%
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
DRUGLiposomal bupivacaine
20 ml
40 mL
DRUGbupivacaine 0.5%
60 mL
DRUG/hydromorphone 0.05mg/ml
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
40 mL
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. Thoracic Epidural Analgesia 2. Rectus Sheath Block 3. Surgeon Infiltration with Liposomal Bupivacaine 4. Standard Bupivacaine
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score at 48 Hour | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose | Opioid comsumption will be measured at 48 hours | Opioid consumption will be collected by a study team member post operatively at hour 48 per protocol time requirements |
| Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | Opioid comsumption will be measured at 72 hours | Opioid consumption will be collected by a study team member post operatively at hour 72 per protocol time requirements |
| Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose | Opioid comsumption will be measured at 96 hours | Opioid consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements |
| VAS Score at 1 Hour | Pain scores will be measured 1 hour 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 24 | Pain scores will be measured 24 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 96 Hour | Pain scores will be measured 96 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 |
| Number of Participants With Nausea at 1 Hour | 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. |
| Number of Participants With Nausea at 24 Hours | 24 hour | Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Result is reported as nausea or no nausea. |
| Number of Participants With Nausea at 48 Hours | 48 hour | Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Result is reported as nausea or no nausea. |
| Number of Participants With Nausea at 72 Hours | 72 hour | Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Result is reported as nausea or no nausea. |
| Number of Participants With Nausea at 96 Hours | 96 hour | Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Result is reported as nausea or no nausea. |
| Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose | Opioid comsumption will be measured at 1 hour | Opioid consumption will be collected by a study team member post operatively at hour 1 per protocol time requirements |
| Number of Participants With Sedation at 24 Hours | 24 hour | 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. |
| Number of Participants With Sedation at 48 Hours | 48 hour | 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. |
| Number of Participants With Sedation at 72 Hours | 72 hour | 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. |
| Number of Participants With Sedation at 96 Hours | 96 hour | 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. |
| First Flatus-bowel Movement | Assess daily until patient passes gas postoperatively, up to 120 hours after surgery | The first time the patients passes gas post operatively. |
| Postoperative Creatinine | Creatinine level will be collected daily postoperatively for 4 days | Lab level of Creatinine will be recorded for 4 days post operatively. |
| Time to Discharge-Length of Stay | From hospital admission to discharge time | Length of Stay will be collected from Cerner Electronic Medical Record. Pt. followed for length of stay, up till 4 weeks after surgery. |
| Incidence of Hypotension | number of times hypotension occurred the first 96 hours after surgery. | 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. |
| Incidence of Respiratory Depression | assess daily as yes/no up to 96hr | Define by use of Narcan |
| Ambulation Activity Postoperatively | Patients followed for ambulation activities on postop Day 1 and Day 2 | Number of participants who got out of bed and is ambulatory on Postoperative Day 1 and postoperative Day 2 |
| Number of Participants With Sedation at 1 Hour | 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. |
| Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose | Opioid comsumption will be measured at 24 hours | Opioid consumption will be collected by a study team member post operatively at hour 24 per protocol time requirements |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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 | 37 |
| 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 | 40 |
| 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 | 38 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Thoracic Epidural | Rectus Sheath Block | Surgeon Infiltration With Liposomal Bupivacaine (LB) | Surgeon Infiltration | Total |
|---|---|---|---|---|---|
| Age, Continuous | 72 years | 70 years | 70 years | 76 years | 72 years |
| Body Mass Index (BMI) inkg/m^2 | 28.5 kg/m^2 | 27.7 kg/m^2 | 27.3 kg/m^2 | 26.8 kg/m^2 | 27.6 kg/m^2 |
| Duration of Surgery-in minutes | 305 minutes | 280.5 minutes | 285.0 minutes | 295.0 minutes | 291.4 minutes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 37 Participants | 40 Participants | 38 Participants | 151 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 7 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 24 Participants | 29 Participants | 33 Participants | 25 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 4 / 40 | 8 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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
Time frame: Pain scores will be measured 48 hours after surgery
Population: 48-hour Pain Scores
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Thoracic Epidural | VAS Score at 48 Hour | 48-hour Pain Scores at Movement | 5 score on a scale |
| Thoracic Epidural | VAS Score at 48 Hour | 48-hour Pain Scores at Rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 48 Hour | 48-hour Pain Scores at Rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 48 Hour | 48-hour Pain Scores at Movement | 7 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 48 Hour | 48-hour Pain Scores at Movement | 4 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 48 Hour | 48-hour Pain Scores at Rest | 3 score on a scale |
| Surgeon Infiltration | VAS Score at 48 Hour | 48-hour Pain Scores at Movement | 6 score on a scale |
| Surgeon Infiltration | VAS Score at 48 Hour | 48-hour Pain Scores at Rest | 2 score on a scale |
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
Time frame: Pain scores will be measured 72 hours after surgery
Population: Pain Scores at 72 hour
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Thoracic Epidural | VAS Score at 72 Hour | 72-hour Pain Scores at Movement | 3.5 score on a scale |
| Thoracic Epidural | VAS Score at 72 Hour | 72-hour Pain Scores at Rest | 1 score on a scale |
| Rectus Sheath Block | VAS Score at 72 Hour | 72-hour Pain Scores at Rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 72 Hour | 72-hour Pain Scores at Movement | 3 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 72 Hour | 72-hour Pain Scores at Movement | 5 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 72 Hour | 72-hour Pain Scores at Rest | 3 score on a scale |
| Surgeon Infiltration | VAS Score at 72 Hour | 72-hour Pain Scores at Movement | 4 score on a scale |
| Surgeon Infiltration | VAS Score at 72 Hour | 72-hour Pain Scores at Rest | 2 score on a scale |
Secondary
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
Population: Ambulation activity
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thoracic Epidural | Ambulation Activity Postoperatively | Patient Starts ambulating on Day 1-Yes | 34 Participants |
| Thoracic Epidural | Ambulation Activity Postoperatively | Patient starts ambulating on Day 2-yes | 1 Participants |
| Rectus Sheath Block | Ambulation Activity Postoperatively | Patient starts ambulating on Day 2-yes | 1 Participants |
| Rectus Sheath Block | Ambulation Activity Postoperatively | Patient Starts ambulating on Day 1-Yes | 35 Participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Ambulation Activity Postoperatively | Patient Starts ambulating on Day 1-Yes | 38 Participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Ambulation Activity Postoperatively | Patient starts ambulating on Day 2-yes | 2 Participants |
| Surgeon Infiltration | Ambulation Activity Postoperatively | Patient Starts ambulating on Day 1-Yes | 36 Participants |
| Surgeon Infiltration | Ambulation Activity Postoperatively | Patient starts ambulating on Day 2-yes | 1 Participants |
Secondary
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
Population: Time to first Flatus
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | First Flatus-bowel Movement | 70.3 Hours |
| Rectus Sheath Block | First Flatus-bowel Movement | 55.5 Hours |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | First Flatus-bowel Movement | 69.7 Hours |
| Surgeon Infiltration | First Flatus-bowel Movement | 59.8 Hours |
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.
Time frame: number of times hypotension occurred the first 96 hours after surgery.
Population: cumulative number of hypotension episodes in 96 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Incidence of Hypotension | 25 hypotension episodes |
| Rectus Sheath Block | Incidence of Hypotension | 22 hypotension episodes |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Incidence of Hypotension | 16 hypotension episodes |
| Surgeon Infiltration | Incidence of Hypotension | 26 hypotension episodes |
Secondary
Incidence of Respiratory Depression
Define by use of Narcan
Time frame: assess daily as yes/no up to 96hr
Population: Incidence of Respiratory Depression
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural | Incidence of Respiratory Depression | 0 Participants |
| Rectus Sheath Block | Incidence of Respiratory Depression | 1 Participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Incidence of Respiratory Depression | 2 Participants |
| Surgeon Infiltration | Incidence of Respiratory Depression | 1 Participants |
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.
Time frame: 1 hour
Population: 1-hour nausea score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Nausea at 1 Hour | 4 participants |
| Rectus Sheath Block | Number of Participants With Nausea at 1 Hour | 5 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Nausea at 1 Hour | 3 participants |
| Surgeon Infiltration | Number of Participants With Nausea at 1 Hour | 4 participants |
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.
Time frame: 24 hour
Population: 24-hour nausea score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Nausea at 24 Hours | 9 participants |
| Rectus Sheath Block | Number of Participants With Nausea at 24 Hours | 5 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Nausea at 24 Hours | 7 participants |
| Surgeon Infiltration | Number of Participants With Nausea at 24 Hours | 9 participants |
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.
Time frame: 48 hour
Population: 48-hour nausea score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Nausea at 48 Hours | 11 participants |
| Rectus Sheath Block | Number of Participants With Nausea at 48 Hours | 11 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Nausea at 48 Hours | 10 participants |
| Surgeon Infiltration | Number of Participants With Nausea at 48 Hours | 13 participants |
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.
Time frame: 72 hour
Population: 72-hour nausea score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Nausea at 72 Hours | 11 participants |
| Rectus Sheath Block | Number of Participants With Nausea at 72 Hours | 12 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Nausea at 72 Hours | 17 participants |
| Surgeon Infiltration | Number of Participants With Nausea at 72 Hours | 18 participants |
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.
Time frame: 96 hour
Population: 96-hour nausea score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Nausea at 96 Hours | 15 participants |
| Rectus Sheath Block | Number of Participants With Nausea at 96 Hours | 6 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Nausea at 96 Hours | 12 participants |
| Surgeon Infiltration | Number of Participants With Nausea at 96 Hours | 14 participants |
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.
Time frame: 1 hour
Population: 1hr sedation score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Sedation at 1 Hour | 2 participants |
| Rectus Sheath Block | Number of Participants With Sedation at 1 Hour | 2 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Sedation at 1 Hour | 2 participants |
| Surgeon Infiltration | Number of Participants With Sedation at 1 Hour | 2 participants |
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.
Time frame: 24 hour
Population: 24-hour sedation score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Sedation at 24 Hours | 1 participants |
| Rectus Sheath Block | Number of Participants With Sedation at 24 Hours | 0 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Sedation at 24 Hours | 0 participants |
| Surgeon Infiltration | Number of Participants With Sedation at 24 Hours | 0 participants |
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.
Time frame: 48 hour
Population: 48-hour sedation score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Sedation at 48 Hours | 2 participants |
| Rectus Sheath Block | Number of Participants With Sedation at 48 Hours | 1 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Sedation at 48 Hours | 2 participants |
| Surgeon Infiltration | Number of Participants With Sedation at 48 Hours | 0 participants |
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.
Time frame: 72 hour
Population: 72-hour sedation score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Sedation at 72 Hours | 0 participants |
| Rectus Sheath Block | Number of Participants With Sedation at 72 Hours | 1 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Sedation at 72 Hours | 2 participants |
| Surgeon Infiltration | Number of Participants With Sedation at 72 Hours | 1 participants |
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.
Time frame: 96 hour
Population: 96-hour sedation score
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Thoracic Epidural | Number of Participants With Sedation at 96 Hours | 1 participants |
| Rectus Sheath Block | Number of Participants With Sedation at 96 Hours | 1 participants |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Number of Participants With Sedation at 96 Hours | 0 participants |
| Surgeon Infiltration | Number of Participants With Sedation at 96 Hours | 2 participants |
Secondary
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
Population: creatinine level Postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Postoperative Creatinine | 1.0 mg/dL |
| Rectus Sheath Block | Postoperative Creatinine | 0.98 mg/dL |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Postoperative Creatinine | 1.08 mg/dL |
| Surgeon Infiltration | Postoperative Creatinine | 0.96 mg/dL |
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
Time frame: Opioid comsumption will be measured at 1 hour
Population: 1-hour opioid consumption
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose | 5.7 milligram morphine equivalents |
| Rectus Sheath Block | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose | 6.5 milligram morphine equivalents |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose | 5.8 milligram morphine equivalents |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose | 4.1 milligram morphine equivalents |
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
Time frame: Opioid comsumption will be measured at 24 hours
Population: Opioid consumption at 24-hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose | 19 milligram morphine equivalents |
| Rectus Sheath Block | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose | 36 milligram morphine equivalents |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose | 52 milligram morphine equivalents |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose | 30 milligram morphine equivalents |
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
Time frame: Opioid comsumption will be measured at 48 hours
Population: Opioid consumption at 48 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose | 24.8 milligram morphine equivalents |
| Rectus Sheath Block | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose | 28 milligram morphine equivalents |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose | 52 milligram morphine equivalents |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose | 44 milligram morphine equivalents |
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
Time frame: Opioid comsumption will be measured at 72 hours
Population: Opioid consumption at 72 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | 26.7 milligram morphine equivalents |
| Rectus Sheath Block | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | 32 milligram morphine equivalents |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | 40 milligram morphine equivalents |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose | 32 milligram morphine equivalents |
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
Time frame: Opioid comsumption will be measured at 96 hours
Population: Opioid consumption at 96 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose | 21.1 milligram morphine equivalents |
| Rectus Sheath Block | Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose | 33 milligram morphine equivalents |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose | 23.3 milligram morphine equivalents |
| Surgeon Infiltration | Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose | 20 milligram morphine equivalents |
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.
Time frame: From hospital admission to discharge time
Population: Length of Stay (LOS)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Thoracic Epidural | Time to Discharge-Length of Stay | 7.1 days |
| Rectus Sheath Block | Time to Discharge-Length of Stay | 6.0 days |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | Time to Discharge-Length of Stay | 6.4 days |
| Surgeon Infiltration | Time to Discharge-Length of Stay | 7.0 days |
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
Time frame: Pain scores will be measured 1 hour after surgery
Population: 1-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Thoracic Epidural | VAS Score at 1 Hour | 1-hour pain scores at movement | 4.4 score on a scale |
| Thoracic Epidural | VAS Score at 1 Hour | 1-hour pain scores ar rest | 3.6 score on a scale |
| Rectus Sheath Block | VAS Score at 1 Hour | 1-hour pain scores ar rest | 3.5 score on a scale |
| Rectus Sheath Block | VAS Score at 1 Hour | 1-hour pain scores at movement | 3.1 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 1 Hour | 1-hour pain scores at movement | 2.9 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 1 Hour | 1-hour pain scores ar rest | 2.7 score on a scale |
| Surgeon Infiltration | VAS Score at 1 Hour | 1-hour pain scores at movement | 2.3 score on a scale |
| Surgeon Infiltration | VAS Score at 1 Hour | 1-hour pain scores ar rest | 1.9 score on a scale |
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
Time frame: Pain scores will be measured 24 hours after surgery
Population: 24-hour Pain Scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Thoracic Epidural | VAS Score at 24 | 24- hour pain score at movement | 5 score on a scale |
| Thoracic Epidural | VAS Score at 24 | 24-hour pain score at rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 24 | 24-hour pain score at rest | 3 score on a scale |
| Rectus Sheath Block | VAS Score at 24 | 24- hour pain score at movement | 7 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 24 | 24-hour pain score at rest | 3 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 24 | 24- hour pain score at movement | 5 score on a scale |
| Surgeon Infiltration | VAS Score at 24 | 24- hour pain score at movement | 6 score on a scale |
| Surgeon Infiltration | VAS Score at 24 | 24-hour pain score at rest | 3 score on a scale |
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
Time frame: Pain scores will be measured 96 hours after surgery
Population: 96-hour pain scores
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Thoracic Epidural | VAS Score at 96 Hour | 96-hour pain score at movement | 4.5 score on a scale |
| Thoracic Epidural | VAS Score at 96 Hour | 96-hour pain score at rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 96 Hour | 96-hour pain score at rest | 2 score on a scale |
| Rectus Sheath Block | VAS Score at 96 Hour | 96-hour pain score at movement | 3 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 96 Hour | 96-hour pain score at movement | 4 score on a scale |
| Surgeon Infiltration With Liposomal Bupivacaine (LB) | VAS Score at 96 Hour | 96-hour pain score at rest | 2 score on a scale |
| Surgeon Infiltration | VAS Score at 96 Hour | 96-hour pain score at movement | 3 score on a scale |
| Surgeon Infiltration | VAS Score at 96 Hour | 96-hour pain score at rest | 1 score on a scale |