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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
Study 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
VAS score at 48 hour
VAS score at 72 hour
Secondary outcome measures
Ambulation Activity
Average Nausea score 1 hour
Average Nausea score 24 hour
+21 moreTrial 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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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,141 Total Patients Enrolled
Yar Yeap, MDPrincipal Investigator - Indiana University Hospital
Indiana University
6 Previous Clinical Trials
530 Total Patients Enrolled
Frequently Asked Questions
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