166 Participants Needed

IV vs Oral Acetaminophen for Spine Surgery Pain Management

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Hospital for Special Surgery, New York
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The United States is currently experiencing an explosive opioid epidemic. In 2014 alone, 28,647 Americans died from an opioid associated overdose; the annual death toll has increased by over 300% since 2000. The epidemic poses a complex scenario for physicians administering treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to severe pain. In order to reduce the patients risk for long term opioid use and the associated side effects, physicians have begun shifting to multimodal analgesic approaches to treat postoperative pain. These approaches have been found to be similarly efficacious, while also reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus. This study proposes a multimodal analgesic approach, which the investigators believe will reduce short and long term opioid usage, the associated side effects, and the financial burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive pain management, however its use is limited by a high cost to perceived benefit ratio. Oral acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV option, and also often not feasible to utilize in the immediate post-operative period when patients are unable to safely swallow pills. The hypothesis of this investigation is to understand if 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.

Research Team

CC

Chad Craig, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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.

Inclusion Criteria

I am mentally and physically capable of following the study's requirements.
I have been diagnosed with spinal stenosis and slipped vertebrae in my lower back.
I have tried non-surgical treatments.
See 2 more

Exclusion Criteria

I have a history of bone conditions and a DEXA score of -2.5 or lower.
I have been taking more than 30mg/day of morphine or its equivalent for over 3 months.
I have a history of Hemochromatosis or Porphyria.
See 22 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Eligible patients receive either IV or oral acetaminophen within 3 hours of OR start time

Immediate preoperative

Postoperative Treatment

Participants receive either IV or oral acetaminophen every 6 hours for 48 hours postoperative, with standardized hydromorphone IV-PCA for 24 hours

48 hours

Follow-up

Participants are monitored for pain management outcomes and opioid usage at 6 weeks and 6 months postoperative

6 months

Treatment Details

Interventions

  • IV vs Oral Acetaminophen
  • Multimodal Analgesic Approach
  • Ofirmev
  • Per Os Acetaminophen
Trial Overview 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.
Participant Groups
2Treatment groups
Active Control
Group I: 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.
Group II: 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials
257
Recruited
61,800+

Mallinckrodt

Industry Sponsor

Trials
202
Recruited
15,700+

Mario Saltarelli

Mallinckrodt

Chief Medical Officer

MD

Siggi Olafsson profile image

Siggi Olafsson

Mallinckrodt

Chief Executive Officer

PhD in Pharmacy