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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
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
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 moreAwards & 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.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,724 Total Patients Enrolled
Yar Yeap, MDPrincipal Investigator - Indiana University Hospital
Indiana University
6 Previous Clinical Trials
530 Total Patients Enrolled