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

Cystectomy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04300231
• Other study ID #: 1905006917
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 22, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 30, 2023
• Est. primary completion date: June 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystectomy
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	Indiana Univeristy	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

ozek, J. J., M. De Ruyter, and T. W. Khan.

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. — View Citation

Sun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Pain scores will be measured 48 hours after surgery
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	Pain scores will be measured 72 hours after surgery
Secondary	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	Opioid comsumption will be measured at 1 hour
Secondary	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	Opioid comsumption will be measured at 24 hours
Secondary	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	Opioid comsumption will be measured at 48 hours
Secondary	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	Opioid comsumption will be measured at 72 hours
Secondary	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	Opioid comsumption will be measured at 96 hours
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	Pain scores will be measured 1 hour after surgery
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	Pain scores will be measured 24 hours after surgery
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	Pain scores will be measured 96 hours after surgery
Secondary	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).	1 hour
Secondary	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).	24 hour
Secondary	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).	48 hour
Secondary	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).	72 hour
Secondary	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).	96 hour
Secondary	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.	1 hour
Secondary	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.	24 hour
Secondary	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.	48 hour
Secondary	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.	72 hour
Secondary	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.	96 hour
Secondary	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.	Assess daily until patient passes gas postoperatively within 72 hours
Secondary	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.	Creatinine level will be collected daily postoperatively for 4 days
Secondary	Time to Discharge-Length of Stay	LOS will be collected via EMR	From hospital admission to discharge date up to 3weeks
Secondary	Incidence of Hypotension	Defined as BP decrease of more than 20% from baseline	daily during 96 hour assessment period
Secondary	Incidence of Respiratory Depression	Define by use of Narcan	assess daily as yes/no
Secondary	Ambulation Activity	Define as anytime out of bed: up in chair, to bathroom or walking hall with PT/nurse	will be recorded daily as yes/no