Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
NCT ID: NCT04300231
Last Updated: 2025-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2019-10-22
2021-12-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
2. Rectus Sheath Block
3. Surgeon Infiltration with Liposomal Bupivacaine
4. Standard Bupivacaine
TREATMENT
NONE
Study Groups
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Thoracic epidural
1\. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.
epidural bupivacaine 0.05%
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
/hydromorphone 0.05mg/ml
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
Rectus Sheath Block
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.
Liposomal bupivacaine
20 ml
bupivacaine 0.125%
40 mL
injectable saline
40 mL
Surgeon Infiltration with Liposomal Bupivacaine (LB)
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.
Liposomal bupivacaine
20 ml
bupivacaine 0.125%
40 mL
injectable saline
40 mL
Surgeon Infiltration
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.
bupivacaine 0.5%
60 mL
injectable saline
40 mL
Interventions
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epidural bupivacaine 0.05%
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
Liposomal bupivacaine
20 ml
bupivacaine 0.125%
40 mL
bupivacaine 0.5%
60 mL
/hydromorphone 0.05mg/ml
Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
injectable saline
40 mL
Eligibility Criteria
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Inclusion Criteria
* ASA class 1, 2, 3 or 4
* Age 18 or older, male or female
* Desires Regional anesthesia for postoperative pain control
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Indiana University
OTHER
Responsible Party
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Yar Yeap
Director, Acute Pain Service, Assistant Professor of Clinical Anesthesiology, Dept of Anesthesiology
Principal Investigators
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Yar Yeap, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University Hospital
Locations
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Indiana Univeristy
Indianapolis, Indiana, United States
Countries
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References
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Butterworth Iv, John F., David C. Mackey, and John D. Wasnick.
de Boer, H. D., O. Detriche, and P. Forget.
Guo, Q., R. Li, L. Wang, D. Zhang, and Y. Ma.
Hou, X., Z. Luo, H. Wang, Y. Zhan, L. Yang, and L. Li.
Kalogera, E., J. N. Bakkum-Gamez, A. L. Weaver, J. P. Moriarty, B. J. Borah, C. L. Langstraat, C. J. Jankowski, et al.
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.
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.
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.
ozek, J. J., M. De Ruyter, and T. W. Khan.
Sun, J. X., K. Y. Bai, Y. F. Liu, G. Du, Z. H. Fu, H. Zhang, J. H. Yang, et al.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1905006917
Identifier Type: -
Identifier Source: org_study_id
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