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

Active, not recruiting

• 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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Primary Completion: 2022-06-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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

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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

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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
Secondary endpoint includes total opioid consumption at 24 hours	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
Secondary endpoint includes total opioid consumption at 1 hour	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 48 hours	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	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	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
Average Nausea score 1 hour	1 hour	Nausea scores will be collected by study team member post operatively at hour 1 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3).
Average Nausea score 24 hour	24 hour	Nausea scores will be collected by study team member post operatively at hour 24 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3).
Average Nausea score 48 hour	48 hour	Nausea scores will be collected by study team member post operatively at hour 48 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3).
Average Nausea score 72 hour	72 hour	Nausea scores will be collected by study team member post operatively at hour 72 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3).
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
Average Nausea score 96 hour	96 hour	Nausea scores will be collected by study team member post operatively at hour 96 per protocol. Nausea will be recorded as none, mild, moderate or severe. Scoring system being (none=0, mild=1, moderate=2 and severe=3).
Average Sedation score at 1 hour	1 hour	Sedation scores will be collected by a study team member post operatively at hour 1 per protocol requirements. Determining if patient is awake \& alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome.
Average Sedation score at 24 hour	24 hour	Sedation scores will be collected by a study team member post operatively at hour 24 per protocol requirements. Determining if patient is awake \& alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome.
Average Sedation score at 48 hour	48 hour	Sedation scores will be collected by a study team member post operatively at hour 48 per protocol requirements. Determining if patient is awake \& alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher scores mean a worse outcome.
Average Sedation score at 72 hour	72 hour	Sedation scores will be collected by a study team member post operatively at hour 72 per protocol requirements. Determining if patient is awake \& alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome.
Average Sedation score at 96 hour	96 hour	Sedation scores will be collected by a study team member post operatively at hour 96 per protocol requirements. Determining if patient is awake \& alert=0, quietly awake=1, asleep and arousable=2 or deep sleep=3. The higher the scores mean a worse outcome.
First Flatus-bowel movement	Assess daily until patient passes gas postoperatively within 72 hours	The passing of gas will be collected by a study team member as per protocol requirements. This is only for the first time the patients passes gas post operatively and is expected to occur during the hospital admission prior to patients discharge. The outcome measure will be assessed through study completion, an average of 1week.
Incidence of Urinary Retention-Postoperative Creatinine	Creatinine level will be collected daily postoperatively for 4 days	Lab level of Creatinine will be collected if only ordered by the surgeon doing the surgery. I will be recorded or documented for 4 days post operatively.
Time to Discharge-Length of Stay	From hospital admission to discharge date up to 3weeks	LOS will be collected via EMR
Incidence of Hypotension	daily during 96 hour assessment period	Defined as BP decrease of more than 20% from baseline
Incidence of Respiratory Depression	assess daily as yes/no	Define by use of Narcan
Ambulation Activity	will be recorded daily as yes/no	Define as anytime out of bed: up in chair, to bathroom or walking hall with PT/nurse

Trial Locations

Locations (1)

Indiana Univeristy; 🇺🇸 Indianapolis, Indiana, United States