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NCT03115151 · ClinicalTrials.gov registry record · Phase 4
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
NCT03115151 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 46 participants.
The verdict
NCT03115151, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
Study Summary
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.
Interventions
- DRUG Bupivacaine
- DRUG Hydromorphone
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2023-04-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03115151
The ClinicalTrials.gov registry entry for NCT03115151 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.
NCT03115151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03115151 about?
NCT03115151 is a clinical study titled "Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery". Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techni...
What is the current status of trial NCT03115151?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2017-05-08. Estimated completion is 2023-04-04.
What interventions are being tested in trial NCT03115151?
The interventions under investigation include: Bupivacaine (DRUG), Hydromorphone (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT03115151?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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