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NCT03723447 · ClinicalTrials.gov registry record · Phase 4
Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
A Phase 4 study of Colorectal Cancer and Pain, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT03723447 is a Phase 4 study of Colorectal Cancer and Pain that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 102 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03723447, a Phase 4 study of Colorectal Cancer and Pain, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-depo formulation of bupivacaine (Exparel) has gained popularity as a long-lasting TAP block medication, but has not been studied in a well-powered clinical trial specifically in colorectal patients nor compared to a bupivacaine/steroid mixture which may offer similar effects. We conduct a prospective randomized prospective randomized study of patients undergoing major laparoscopic colorectal surgery to compare the analgesic effects of a bupivacaine/steroid mixture versus liposomal bupivacaine.
Conditions Studied
Interventions
- DRUG Liposomal bupivacaine
- DRUG Bupivacaine/epinephrine/dexamethasone
Study Locations (1)
California
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03723447
The ClinicalTrials.gov registry entry for NCT03723447 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT03723447 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03723447 about?
NCT03723447 is a clinical study titled "Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)". Traditionally, opioids are heavily utilized in treating postoperative pain but they are associated with numerous side effects. The use of the transversus abdominis plane (TAP) blocks have become standard practice to extend the post-operative analgesic window and limit opioid use. A new liposomal-dep...
What is the current status of trial NCT03723447?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2018-10-23. Estimated completion is 2019-10-29.
What conditions does trial NCT03723447 study?
This clinical trial studies the following conditions: Colorectal Cancer, Pain, Pain, Postoperative, Crohn Disease, Inflammatory Bowel Diseases.
What interventions are being tested in trial NCT03723447?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Bupivacaine/epinephrine/dexamethasone (DRUG).
Who is sponsoring clinical trial NCT03723447?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03723447 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.