The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
Public ClinicalTrials.gov record NCT03104816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion: a Prospective, Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03104816
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2016
- Primary completion
- Sep 30, 2017
- Completion
- Nov 30, 2017
- Last update posted
- Oct 7, 2019
2016 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03104816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03104816 live on ClinicalTrials.gov.