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NCT03104816 · ClinicalTrials.gov registry record · Phase 4
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
A Phase 4 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT03104816: Clinical Trial Phase 4 study, sponsored by University of Southern California.
NCT03104816 is a Phase 4 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104816, a Phase 4 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
Simple explanation and rationale: Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids. It is common practice to supplement opioid treatment with different classes of analgesics which work through alternative pain pathways and receptors in order to achieve an additive or synergistic effect while reducing the amount of opioids necessary for pain control. Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain relief. Intervention: Patients will be randomized to either the treatment with IV acetaminophen (A), PO acetaminophen (B), or hydromorphone control group (C). Objective/Purpose: Primary objective is to determine the impact of administering a supplemental non-opioid analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the postoperative period. Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of postoperative pain, patient satisfaction, and side effects secondary to opioids such as nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention, and PACU (postoperative care unit) discharge time. Study population: 126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for control group C). Follow-up and Endpoints / Outcomes: Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24 hours after surgery. Patients will be evaluated for pain (using a numeric rating scale), total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey sedation scale and the Aldrete score at the time of arrival to and discharge from recovery room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also be assessed using a numeric rating scale.
Primary Outcome
Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.
Interventions
- DRUG Acetaminophen
- DRUG Hydromorphone
- DRUG Acetaminophen IV Soln 10 MG/ML
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
Why NCT03104816 stopped before completion
NCT03104816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Acetaminophen is the first listed.
NCT03104816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03104816 about?
NCT03104816 is a clinical study titled "The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion". Simple explanation and rationale: Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids. It is common practice to supplement opioid treatment with different classes of analgesics which work through alternative pain pathways and receptor...
What is the current status of trial NCT03104816?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2016-10. Estimated completion is 2017-12.
What interventions are being tested in trial NCT03104816?
The interventions under investigation include: Acetaminophen (DRUG), Hydromorphone (DRUG), Acetaminophen IV Soln 10 MG/ML (DRUG).
Who is sponsoring clinical trial NCT03104816?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03104816's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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