Phase 3
N=160
Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy
Cystectomy
Bottom Line
View on ClinicalTrials.gov: NCT04300231 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: VAS Score at 48 Hour — 5; 7; 4; 6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- epidural bupivacaine 0.05% (Drug); Liposomal bupivacaine (Drug); bupivacaine 0.125% (Drug); bupivacaine 0.5% (Drug); /hydromorphone 0.05mg/ml (Drug); injectable saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS Score at 48 Hour |
5; 7; 4; 6; 2; 2 | — |
| PRIMARY VAS Score at 72 Hour |
3.5; 3; 5; 4; 1; 2 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 1 Hour Per PO Morphine Equivalent Dose |
5.7; 6.5; 5.8; 4.1 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 24 Hours PO Morphine Equivalent Dose |
19; 36; 52; 30 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 48 Hours PO Morphine Equivalent Dose |
24.8; 28; 52; 44 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 72 Hours PO Morphine Equivalent Dose |
26.7; 32; 40; 32 | — |
| SECONDARY Secondary Endpoint Includes Total Opioid Consumption at 96 Hours PO Morphine Equivalent Dose |
21.1; 33; 23.3; 20 | — |
| SECONDARY VAS Score at 1 Hour |
4.4; 3.1; 2.9; 2.3; 3.6; 3.5 | — |
| SECONDARY VAS Score at 24 |
5; 7; 5; 6; 2; 3 | — |
| SECONDARY VAS Score at 96 Hour |
4.5; 3; 4; 3; 2; 2 | — |
| SECONDARY Number of Participants With Nausea at 1 Hour |
4; 5; 3; 4 | — |
| SECONDARY Number of Participants With Nausea at 24 Hours |
9; 5; 7; 9 | — |
| SECONDARY Number of Participants With Nausea at 48 Hours |
11; 11; 10; 13 | — |
| SECONDARY Number of Participants With Nausea at 72 Hours |
11; 12; 17; 18 | — |
| SECONDARY Number of Participants With Nausea at 96 Hours |
15; 6; 12; 14 | — |
| SECONDARY Number of Participants With Sedation at 1 Hour |
2; 2; 2; 2 | — |
| SECONDARY Number of Participants With Sedation at 24 Hours |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Sedation at 48 Hours |
2; 1; 2; 0 | — |
| SECONDARY Number of Participants With Sedation at 72 Hours |
0; 1; 2; 1 | — |
| SECONDARY Number of Participants With Sedation at 96 Hours |
1; 1; 0; 2 | — |
| SECONDARY First Flatus-bowel Movement |
70.3; 55.5; 69.7; 59.8 | — |
| SECONDARY Postoperative Creatinine |
1.0; 0.98; 1.08; 0.96 | — |
| SECONDARY Time to Discharge-Length of Stay |
7.1; 6.0; 6.4; 7.0 | — |
| SECONDARY Incidence of Hypotension |
25; 22; 16; 26 | — |
| SECONDARY Incidence of Respiratory Depression |
0; 1; 2; 1 | — |
| SECONDARY Ambulation Activity Postoperatively |
34; 35; 38; 36; 1; 1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patients undergoing cystectomy for bladder cancer
- ASA class 1, 2, 3 or 4
- Age 18 or older, male or female
- Desires Regional anesthesia for postoperative pain control
Exclusion Criteria
- Any contraindication for thoracic epidural.
- 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
Data sourced from ClinicalTrials.gov (NCT04300231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.