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

NCT04300231 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 1905006917
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (24)

• Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose

  Opioid comsumption will be measured at 1 hour

• Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose

  Opioid comsumption will be measured at 24 hours

• Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose

  Opioid comsumption will be measured at 48 hours

• Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose

  Opioid comsumption will be measured at 72 hours

• Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose

  Opioid comsumption will be measured at 96 hours

Study Arms (4)

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.

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.

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.

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.

Drug: bupivacaine 0.5%; Drug: injectable saline

Interventions

epidural bupivacaine 0.05% DRUG

Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.

Thoracic epidural

Liposomal bupivacaine DRUG

20 ml

Rectus Sheath Block; Surgeon Infiltration with Liposomal Bupivacaine (LB)

bupivacaine 0.125% DRUG

40 mL

Rectus Sheath Block; Surgeon Infiltration with Liposomal Bupivacaine (LB)

bupivacaine 0.5% DRUG

60 mL

Surgeon Infiltration

/hydromorphone 0.05mg/ml DRUG

Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.

Thoracic epidural

injectable saline DRUG

40 mL

Rectus Sheath Block; Surgeon Infiltration; Surgeon Infiltration with Liposomal Bupivacaine (LB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana Univeristy

Indianapolis, Indiana, 46202, United States

Location

Related Publications (10)

• Butterworth Iv, John F., David C. Mackey, and John D. Wasnick.

  BACKGROUND

• de Boer, H. D., O. Detriche, and P. Forget.

  BACKGROUND

• Guo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma.

  BACKGROUND

• Hou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li.

  BACKGROUND

• Kalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al.

  BACKGROUND

• 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.

  PMID: 18595236 BACKGROUND

• 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.

  PMID: 25509242 BACKGROUND

• 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.

  PMID: 15711112 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Hydromorphone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Yar Luan Yeap, MD
• Organization: Indiana University Department of Anesthesiology

yyeap@iupui.edu

317-274-0275

Study Officials

• Yar Yeap, MD

  Indiana University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Acute Pain Service, Assistant Professor of Clinical Anesthesiology, Dept of Anesthesiology

Model Details: 1. Thoracic Epidural Analgesia 2. Rectus Sheath Block 3. Surgeon Infiltration with Liposomal Bupivacaine 4. Standard Bupivacaine

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: March 9, 2020
• Study Start: October 22, 2019
• Primary Completion: December 23, 2021
• Study Completion: December 24, 2021
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)