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IV vs Oral Acetaminophen for Spine Surgery Pain Management

Phase 4
Waitlist Available
Led By Chad Craig, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis
Skeletally mature adults between the ages of 18-85 years at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 6 weeks and 6 months postoperative
Awards & highlights

Study Summary

This trial is investigating whether adding intravenous acetaminophen to the perioperative care regimen after lumbar spinal surgery will result in improved pain management in the perioperative period while decreasing opioid usage and related complications.

Who is the study for?
Adults aged 18-85 with lumbar spinal stenosis and degenerative spondylolisthesis, who've tried conservative therapy and have significant leg or back pain. Excludes those with prior fusion surgery at the same level, extreme BMI values, certain infections or immune conditions, severe diabetes, osteoporosis with a specific severity, active cancer within 5 years (except skin cancer), pregnant/lactating women, ongoing litigation related to spine condition, high opioid use history (>30mg/day for over 3 months), inability to take oral meds, liver disease of a certain severity (Child Pugh B-D), Cauda Equina Syndrome or similar neural issues not caused by spinal stenosis.Check my eligibility
What is being tested?
The trial is testing whether IV acetaminophen (Ofirmev) can improve pain management after lumbar spinal surgery compared to oral acetaminophen while reducing opioid usage and complications. The goal is to see if IV administration during perioperative care offers better outcomes in terms of pain control and fewer side effects from opioids.See study design
What are the potential side effects?
Potential side effects include allergic reactions to acetaminophen which could manifest as rash or swelling. Both forms may cause gastrointestinal discomfort like nausea or constipation. Overuse can lead to liver damage especially when combined with alcohol consumption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with spinal stenosis and slipped vertebrae in my lower back.
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I am between 18 and 85 years old and my bones have stopped growing.
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My leg or back pain is more than 40 on a scale of 100.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 6 weeks and 6 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, 6 weeks and 6 months postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual Analog Scale (VAS) for back and legs
Secondary outcome measures
Length of Stay (LOS)
Long Term Opioid Usage
Opioids
+2 more

Trial Design

2Treatment groups
Active Control
Group I: PO AcetaminophenActive Control1 Intervention
Preop: Eligible patients will receive oral acetaminophen within 3 hours of OR start time. Postop: Eligible patients will be administered oral acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following: • Oral Acetaminophen 1,000 mg every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of oral acetaminophen. Postop supplemental pain medications: All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.
Group II: Intravenous AcetaminophenActive Control1 Intervention
Preop: Eligible patients will receive IV acetaminophen within 3 hours of OR start time. Postop: Eligible patients will be administered IV acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following: • IV Acetaminophen 1,000 mg [100 ml] every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of IV acetaminophen. Postop supplemental pain medications: All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.

Find a Location

Who is running the clinical trial?

MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,062 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
243 Previous Clinical Trials
59,164 Total Patients Enrolled
Chad Craig, MDPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

IV vs Oral Acetaminophen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03020875 — Phase 4
Multimodal Analgesia Research Study Groups: PO Acetaminophen, Intravenous Acetaminophen
Multimodal Analgesia Clinical Trial 2023: IV vs Oral Acetaminophen Highlights & Side Effects. Trial Name: NCT03020875 — Phase 4
IV vs Oral Acetaminophen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03020875 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants aged 35 or older being considered for this trial?

"This medical trial mandates that only people aged 18 to 85 can participate in the clinical experiment."

Answered by AI

Has the Food and Drug Administration acknowledged PO Acetaminophen for use?

"The safety profile of PO Acetaminophen was scored as a 3 since it has passed Phase 4 trials and is now approved for use."

Answered by AI

What conditions commonly respond to PO Acetaminophen treatment?

"Catarrh is typically treated with oral Acetaminophen. This medication may also be effective in managing rhinorrhoea, musculoskeletal discomfort, and muscular spasms."

Answered by AI

Could you outline what other experiments have been done utilizing PO Acetaminophen?

"At present, 90 clinical trials are investigating the potential of PO Acetaminophen with 27 in their third phase. Although many studies occur in Pittsburgh, Pennsylvania, there is a total of 1004 sites conducting this research worldwide."

Answered by AI

How many individuals have enrolled in this research trial thus far?

"At present, no more participants are being accepted for this clinical trial. It was posted on January 1st 2017 and the last update occurred on March 29th 2022. If you're looking to join other trials, there is a multimodal analgesic approach study that still needs patients as well as 90 studies recruiting individuals taking PO Acetaminophen."

Answered by AI

To what population is this investigation accessible?

"Aspiring applicants to this medical trial must have utilized an analgesic approach and be between 18-85 years old. Around 166 participants are sought for the study."

Answered by AI

Is this research endeavor presently recruiting participants?

"The clinicaltrials.gov data indicates that the present trial is not actively recruiting patients and was last updated on March 29th, 2022. Despite this, 91 other studies are currently enrolling participants at this moment in time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IV vs Oral Acetaminophen in Spine Fusion Perioperative Care
2017. "IV vs Oral Acetaminophen in Spine Fusion Perioperative Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03020875.
~15 spots leftby Mar 2025
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