IV vs Oral Acetaminophen for Spine Surgery Pain Management
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Eligible patients receive either IV or oral acetaminophen within 3 hours of OR start time
Postoperative Treatment
Participants receive either IV or oral acetaminophen every 6 hours for 48 hours postoperative, with standardized hydromorphone IV-PCA for 24 hours
Follow-up
Participants are monitored for pain management outcomes and opioid usage at 6 weeks and 6 months postoperative
Treatment Details
Interventions
- IV vs Oral Acetaminophen
- Multimodal Analgesic Approach
- Ofirmev
- Per Os Acetaminophen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital for Special Surgery, New York
Lead Sponsor
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy