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

Primary Purpose

Cystectomy

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
epidural bupivacaine 0.05%
Liposomal bupivacaine
bupivacaine 0.125%
bupivacaine 0.5%
/hydromorphone 0.05mg/ml
injectable saline
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana Univeristy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Thoracic epidural

Rectus Sheath Block

Surgeon Infiltration with Liposomal Bupivacaine (LB)

Surgeon Infiltration

Arm Description

1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Secondary endpoint includes total opioid consumption 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
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 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 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 consumption will be collected by a study team member post operatively at hour 96 per protocol time requirements
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
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
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
Average Nausea score 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
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
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
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).
Average Nausea score 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
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
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
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
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
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
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
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
LOS will be collected via EMR
Incidence of Hypotension
Defined as BP decrease of more than 20% from baseline
Incidence of Respiratory Depression
Define by use of Narcan
Ambulation Activity
Define as anytime out of bed: up in chair, to bathroom or walking hall with PT/nurse

Full Information

First Posted
December 12, 2019
Last Updated
May 15, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT04300231
Brief Title
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Official Title
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
June 12, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Decreased opioid requirements Improved postoperative VAS pain scores Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression) Decreased hospital length of stay (LOS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Thoracic Epidural Analgesia Rectus Sheath Block Surgeon Infiltration with Liposomal Bupivacaine Standard Bupivacaine
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracic epidural
Arm Type
Active Comparator
Arm Description
1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
Arm Title
Rectus Sheath Block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgeon Infiltration with Liposomal Bupivacaine (LB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgeon Infiltration
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
epidural bupivacaine 0.05%
Intervention Description
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
20 ml
Intervention Type
Drug
Intervention Name(s)
bupivacaine 0.125%
Intervention Description
40 mL
Intervention Type
Drug
Intervention Name(s)
bupivacaine 0.5%
Intervention Description
60 mL
Intervention Type
Drug
Intervention Name(s)
/hydromorphone 0.05mg/ml
Intervention Description
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
Intervention Type
Drug
Intervention Name(s)
injectable saline
Intervention Description
40 mL
Primary Outcome Measure Information:
Title
VAS score at 48 hour
Description
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
Title
VAS score at 72 hour
Description
The VAS score will be taken with both rest and movement (knee flexion) and will be measured by a study team investigator using Visual Analog Scale (VAS). Using a scale of 0-10 for documentation with 10 being the worst pain and 0 being no pain
Time Frame
Pain scores will be measured 72 hours after surgery
Secondary Outcome Measure Information:
Title
Secondary endpoint includes total opioid consumption at 1 hour
Description
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
Title
Secondary endpoint includes total opioid consumption at 24 hours
Description
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
Title
Secondary endpoint includes total opioid consumption at 48 hours
Description
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
Title
Secondary endpoint includes total opioid consumption at 72 hours
Description
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
Title
Secondary endpoint includes total opioid consumption at 96 hours
Description
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
Title
VAS score at 1 hour
Description
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
Title
VAS score at 24
Description
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
Title
VAS score at 96 hour
Description
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
Title
Average Nausea score 1 hour
Description
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).
Time Frame
1 hour
Title
Average Nausea score 24 hour
Description
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).
Time Frame
24 hour
Title
Average Nausea score 48 hour
Description
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).
Time Frame
48 hour
Title
Average Nausea score 72 hour
Description
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).
Time Frame
72 hour
Title
Average Nausea score 96 hour
Description
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).
Time Frame
96 hour
Title
Average Sedation score at 1 hour
Description
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.
Time Frame
1 hour
Title
Average Sedation score at 24 hour
Description
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.
Time Frame
24 hour
Title
Average Sedation score at 48 hour
Description
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.
Time Frame
48 hour
Title
Average Sedation score at 72 hour
Description
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.
Time Frame
72 hour
Title
Average Sedation score at 96 hour
Description
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.
Time Frame
96 hour
Title
First Flatus-bowel movement
Description
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.
Time Frame
Assess daily until patient passes gas postoperatively within 72 hours
Title
Incidence of Urinary Retention-Postoperative Creatinine
Description
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 Frame
Creatinine level will be collected daily postoperatively for 4 days
Title
Time to Discharge-Length of Stay
Description
LOS will be collected via EMR
Time Frame
From hospital admission to discharge date up to 3weeks
Title
Incidence of Hypotension
Description
Defined as BP decrease of more than 20% from baseline
Time Frame
daily during 96 hour assessment period
Title
Incidence of Respiratory Depression
Description
Define by use of Narcan
Time Frame
assess daily as yes/no
Title
Ambulation Activity
Description
Define as anytime out of bed: up in chair, to bathroom or walking hall with PT/nurse
Time Frame
will be recorded daily as yes/no

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yar Yeap, MD
Organizational Affiliation
Indiana University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana Univeristy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

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