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

Phase 3

Completed

Conditions: Cystectomy

Interventions: Drug: epidural bupivacaine 0.05%
Drug: Liposomal bupivacaine
Drug: bupivacaine 0.5%
Drug: /hydromorphone 0.05mg/ml
Drug: bupivacaine 0.125%
Drug: injectable saline

Registration Number: NCT04300231

Lead Sponsor: Indiana University

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)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic epidural	epidural bupivacaine 0.05%	1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
Thoracic epidural	/hydromorphone 0.05mg/ml	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	Liposomal bupivacaine	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.
Rectus Sheath Block	bupivacaine 0.125%	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.
Rectus Sheath Block	injectable saline	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)	Liposomal bupivacaine	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 with Liposomal Bupivacaine (LB)	bupivacaine 0.125%	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 with Liposomal Bupivacaine (LB)	injectable saline	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	bupivacaine 0.5%	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.
Surgeon Infiltration	injectable saline	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of Respiratory Depression	assess daily as yes/no up to 96hr	Define by use of Narcan
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
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.
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.
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
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 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.
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.
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
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
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 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 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.
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 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 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 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 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.
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.
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