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Rectus Sheath Block for Cystectomy

Phase 3

Waitlist Available

Led By Yar Yeap, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assess daily as yes/no

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test four different methods of controlling pain during and after surgery for patients who are having their bladder removed.

Eligible Conditions

Cystectomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VAS score at 48 hour

VAS score at 72 hour

Secondary study objectives

Ambulation Activity

Average Nausea score 1 hour

Average Nausea score 24 hour

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Active Control

Group I: Rectus Sheath BlockActive Control3 Interventions

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.

Group II: Surgeon InfiltrationActive Control2 Interventions

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.

Group III: Thoracic epiduralActive Control2 Interventions

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

Group IV: Surgeon Infiltration with Liposomal Bupivacaine (LB)Active Control3 Interventions

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.

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