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Opioid Analgesic

Acetaminophen IV Soln 10 MG/ML (A) for Lumbar Spine Fusion

Phase 4
Waitlist Available
Led By Eugenia Ayrian
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA (American Society of Anesthesiologists) I-III patients scheduled for elective one or two level minimally invasive lumbar fusions
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours after surgery
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Opioid Use

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: PO acetaminophen (B)Experimental Treatment2 Interventions
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Group II: Acetaminophen IV Soln 10 MG/ML (A)Experimental Treatment2 Interventions
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Group III: Hydromorphone (control arm) (C)Active Control1 Intervention
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetaminophen
FDA approved
Hydromorphone
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
919 Previous Clinical Trials
1,611,413 Total Patients Enrolled
Eugenia AyrianPrincipal InvestigatorUniversity of Southern California
~3 spots leftby Aug 2025