CystectomyPhase 3NCT04300231

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

A Phase 3 study testing epidural bupivacaine 0.05%, Liposomal bupivacaine and bupivacaine 0.125% in people with Cystectomy, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystectomy
What is being tested?: epidural bupivacaine 0.05%, Liposomal bupivacaine and bupivacaine 0.125%
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteUnited States
Study dates: 22 Oct 2019to 24 Dec 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana Univeristy
Indianapolis, Indiana, 46202

Other trials in United States

About this study

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).

Read the 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)

Conditions: Cystectomy
Being tested: epidural bupivacaine 0.05%, Liposomal bupivacaine, bupivacaine 0.125%, bupivacaine 0.5%, /hydromorphone 0.05mg/ml

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

epidural bupivacaine 0.05%Drug
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
Liposomal bupivacaineDrug
20 ml
bupivacaine 0.125%Drug
40 mL
bupivacaine 0.5%Drug
60 mL
/hydromorphone 0.05mg/mlDrug
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
injectable salineDrug
40 mL

Study groups in NCT04300231
Study group	Role	What they receive
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. Receives: Drug: epidural bupivacaine 0.05%; Drug: /hydromorphone 0.05mg/ml
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. Receives: Drug: Liposomal bupivacaine; Drug: bupivacaine 0.125%; Drug: injectable saline
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. Receives: Drug: Liposomal bupivacaine; Drug: bupivacaine 0.125%; Drug: injectable saline
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. Receives: Drug: bupivacaine 0.5%; Drug: injectable saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: Pain scores will be measured 72 hours after surgery

Secondary outcomes (24)

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
Measured: Opioid comsumption will be measured at 1 hour
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 96 hour
First Flatus-bowel Movement
The first time the patients passes gas post operatively.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: number of times hypotension occurred the first 96 hours after surgery.
Incidence of Respiratory Depression
Define by use of Narcan
Measured: 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
Measured: Patients followed for ambulation activities on postop Day 1 and Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 201924 Dec 2021

First posted9 Mar 2020
Study start22 Oct 2019
Primary completion23 Dec 2021
Study completion24 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for CystectomyStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 1. Thoracic Epidural Analgesia 2. Rectus Sheath Block 3. Surgeon Infiltration with Liposomal Bupivacaine 4. Standard Bupivacaine
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04300231
Sponsor's protocol ID: 1905006917
Status last verified: Feb 2025
First submitted: 12 Dec 2019
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Butterworth Iv, John F., David C. Mackey, and John D. Wasnick.
de Boer, H. D., O. Detriche, and P. Forget.
Guo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma.
Hou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li.
Kalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al.
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.
PubMed 18595236
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.
PubMed 25509242
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.
PubMed 15711112
ozek, J. J., M. De Ruyter, and T. W. Khan.
Sun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Bladder Cancer
Active, not recruitingPhase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Urinary Bladder Neoplasms
Not yet recruiting
EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
Bladder Carcinoma
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Not yet recruitingObservational study
Hugo™ RAS Urology Post-Market Clinical Study
Prostatectomy, Cystectomy

All Cystectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04300231
Acronym / sponsor ID: 1905006917
Conditions: Cystectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 22 Oct 2019 (actual)
Primary completion: 23 Dec 2021 (actual)
Study completion: 24 Dec 2021 (actual)
First posted: 9 Mar 2020 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: 1. Thoracic Epidural Analgesia 2. Rectus Sheath Block 3. Surgeon Infiltration with Liposomal Bupivacaine 4. Standard Bupivacaine

Arm	Type	Receives
Thoracic epidural	Active comparator	Drug: epidural bupivacaine 0.05%, Drug: /hydromorphone 0.05mg/ml1. 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	Drug: Liposomal bupivacaine, Drug: bupivacaine 0.125%, Drug: injectable saline2. 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	Drug: Liposomal bupivacaine, Drug: bupivacaine 0.125%, Drug: injectable saline3. 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	Drug: bupivacaine 0.5%, Drug: injectable saline4. 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
epidural bupivacaine 0.05%Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.	Drug	Thoracic epidural
Liposomal bupivacaine20 ml	Drug	Rectus Sheath Block, Surgeon Infiltration with Liposomal Bupivacaine (LB)
bupivacaine 0.125%40 mL	Drug	Rectus Sheath Block, Surgeon Infiltration with Liposomal Bupivacaine (LB)
bupivacaine 0.5%60 mL	Drug	Surgeon Infiltration
/hydromorphone 0.05mg/mlMix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.	Drug	Thoracic epidural
injectable saline40 mL	Drug	Rectus Sheath Block, Surgeon Infiltration, Surgeon Infiltration with Liposomal Bupivacaine (LB)

Primary outcome

VAS Score at 48 Hour
Time frame: 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
Time frame: 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

24 secondary outcomes

Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose
Time frame: Opioid comsumption will be measured at 1 hour
Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose
Time frame: Opioid comsumption will be measured at 24 hours
Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose
Time frame: Opioid comsumption will be measured at 48 hours
Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose
Time frame: Opioid comsumption will be measured at 72 hours
Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose
Time frame: Opioid comsumption will be measured at 96 hours
VAS Score at 1 Hour
Time frame: Pain scores will be measured 1 hour after surgery
VAS Score at 24
Time frame: Pain scores will be measured 24 hours after surgery
VAS Score at 96 Hour
Time frame: Pain scores will be measured 96 hours after surgery
Number of Participants With Nausea at 1 Hour
Time frame: 1 hour
Number of Participants With Nausea at 24 Hours
Time frame: 24 hour
Number of Participants With Nausea at 48 Hours
Time frame: 48 hour
Number of Participants With Nausea at 72 Hours
Time frame: 72 hour
Number of Participants With Nausea at 96 Hours
Time frame: 96 hour
Number of Participants With Sedation at 1 Hour
Time frame: 1 hour
Number of Participants With Sedation at 24 Hours
Time frame: 24 hour
Number of Participants With Sedation at 48 Hours
Time frame: 48 hour
Number of Participants With Sedation at 72 Hours
Time frame: 72 hour
Number of Participants With Sedation at 96 Hours
Time frame: 96 hour
First Flatus-bowel Movement
Time frame: Assess daily until patient passes gas postoperatively, up to 120 hours after surgery
Postoperative Creatinine
Time frame: Creatinine level will be collected daily postoperatively for 4 days
Time to Discharge-Length of Stay
Time frame: From hospital admission to discharge time
Incidence of Hypotension
Time frame: number of times hypotension occurred the first 96 hours after surgery.
Incidence of Respiratory Depression
Time frame: assess daily as yes/no up to 96hr
Ambulation Activity Postoperatively
Time frame: Patients followed for ambulation activities on postop Day 1 and Day 2

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Thoracic Epidural	40	36
Rectus Sheath Block	40	37
Surgeon Infiltration With Liposomal Bupivacaine (LB)	40	40
Surgeon Infiltration	40	38

Primary outcome: VAS Score at 48 Hour

Time frame: Pain scores will be measured 48 hours after surgery. Median (Full Range). Unit: score on a scale

Measure	Thoracic Epidural n = 36	Rectus Sheath Block n = 37	Surgeon Infiltration With Liposomal Bupivacaine (LB) n = 40	Surgeon Infiltration n = 38
48-hour Pain Scores at Movement	5 (1.5 to 7.5)	7 (4 to 8)	4 (4 to 8)	6 (4 to 9)
48-hour Pain Scores at Rest	2 (0 to 4)	2 (1 to 5)	3 (2 to 5)	2 (0 to 4)

Population analysed: 48-hour Pain Scores

Primary outcome: VAS Score at 72 Hour

Time frame: Pain scores will be measured 72 hours after surgery. Mean (Full Range). Unit: score on a scale

Measure	Thoracic Epidural n = 36	Rectus Sheath Block n = 37	Surgeon Infiltration With Liposomal Bupivacaine (LB) n = 40	Surgeon Infiltration n = 38
72-hour Pain Scores at Movement	3.5 (1 to 5.5)	3 (2 to 5)	5 (4 to 7)	4 (2 to 5)
72-hour Pain Scores at Rest	1 (0 to 2)	2 (0 to 4)	3 (1 to 6)	2 (0 to 3)

Population analysed: Pain Scores at 72 hour

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for up to 3 weeks of hospitalization stay. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Thoracic Epidural	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Rectus Sheath Block	0 of 40 (0%)	4 of 40 (10%)	0 of 40
Surgeon Infiltration With Liposomal Bupivacaine (LB)	0 of 40 (0%)	8 of 40 (20%)	0 of 40
Surgeon Infiltration	0 of 40 (0%)	2 of 40 (5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundButterworth Iv, John F., David C. Mackey, and John D. Wasnick.
Backgroundde Boer, H. D., O. Detriche, and P. Forget.
BackgroundGuo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma.
BackgroundHou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li.
BackgroundKalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al.
Background: PubMed 18595236Ladjevic 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.
Background: PubMed 25509242Mazul-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.
Background: PubMed 15711112Ozyuvaci 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.
Backgroundozek, J. J., M. De Ruyter, and T. W. Khan.
BackgroundSun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al.
Individual participant dataSharing planned: No

Related trials for Cystectomy

Recruiting
Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy
Bladder Cancer
Active, not recruitingPhase 2
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Urinary Bladder Neoplasms
Not yet recruiting
EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
Bladder Carcinoma
RecruitingObservational study
Increasing Pre-Surgical Identification of Muscle Invasive Tumor Evaluations Prior to Planned Cystectomy (INSITE)
Urothelial Carcinoma, Muscle Invasive Bladder Urothelial Carcinoma
Not yet recruitingObservational study
Hugo™ RAS Urology Post-Market Clinical Study
Prostatectomy, Cystectomy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yar Yeap, MD principal investigator

Indiana University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epidural bupivacaine 0.05%, Liposomal bupivacaine and bupivacaine 0.125% in people with Cystectomy, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Score at 48 Hour (time frame: Pain scores will be measured 48 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300231, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.