NCT04300231

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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)

Conditions

• Cystectomy

Interventions

Type	Name	Description
DRUG	epidural bupivacaine 0.05%	Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
DRUG	Liposomal bupivacaine	20 ml
DRUG	bupivacaine 0.125%	40 mL
DRUG	bupivacaine 0.5%	60 mL
DRUG	/hydromorphone 0.05mg/ml	Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
DRUG	injectable saline	40 mL

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-12-23
• Completion: 2021-12-24
• First posted: 2020-03-09
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study