IV vs Oral Acetaminophen for Spine Surgery Pain Management

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Must not be taking: Isoniazid, Barbiturates

Disqualifiers: Obesity, Infection, Diabetes, Cancer, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether intravenous (IV) acetaminophen manages pain after spine surgery more effectively than oral acetaminophen. By comparing these two forms, the researchers hope to reduce the need for opioids, which can cause serious side effects and significantly contribute to the opioid crisis. Suitable candidates for this trial include those diagnosed with lumbar spinal stenosis (narrowing of the spinal canal) who have not found success with other treatments. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking more than 30mg/day of oral morphine sulfate or certain other medications like Isoniazid or barbiturates.

What is the safety track record for IV and oral acetaminophen?

Research has shown that both IV (intravenous) and oral acetaminophen are safe options for managing pain. IV acetaminophen can reduce the need for morphine after surgery, potentially lowering the risk of opioid-related side effects. One study highlighted its effectiveness as an alternative to opioids, reducing side effects like nausea and vomiting.

Oral acetaminophen is also recognized for its safety and is commonly used as a non-opioid pain reliever. It is generally well-tolerated by patients, similar to IV acetaminophen, making it a reliable option for pain management.

In summary, both IV and oral acetaminophen are considered safe for pain management. They are well-tolerated and have a low risk of serious side effects, making them suitable for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about comparing intravenous (IV) and oral acetaminophen for managing pain after spine surgery because each method offers unique benefits. IV acetaminophen delivers the medication directly into the bloodstream, potentially providing faster pain relief compared to oral options, which have to pass through the digestive system first. On the other hand, oral acetaminophen is more convenient and easier to administer outside of a hospital setting, making it a practical choice for ongoing pain management after surgery. This trial aims to determine which method offers the best balance of effectiveness and convenience, potentially improving recovery experiences for patients undergoing spine surgery.

What evidence suggests that this trial's treatments could be effective for spine surgery pain management?

This trial will compare the effectiveness of intravenous (IV) acetaminophen with oral acetaminophen for managing pain after spine surgery. Studies have shown that IV acetaminophen can effectively manage pain and reduce the need for opioids post-surgery. Research indicates that IV acetaminophen works faster than the pill form, which is crucial immediately after surgery. Although IV acetaminophen is usually more expensive, it is considered a safe and effective option and may lower the risk of opioid-related side effects. Conversely, oral acetaminophen can provide similar pain relief after surgeries like joint replacements. It can be effective when combined with other pain medications, helping to reduce opioid use. Both forms of acetaminophen offer benefits, and the choice may depend on factors like cost and the patient's condition after surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Chad Craig, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intravenous Acetaminophen Active Control 1 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 Acetaminophen Active Control 1 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.

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

Mallinckrodt

Chief Executive Officer

PhD in Pharmacy

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12540975/

Effect of the intravenous acetaminophen clinical pathway ... Spinal-fusion surgery, in particular, has a high level of pain, and we found that pain management for this surgery was inadequate at our ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03261310

Study Details | NCT03261310 | Use of IV Acetaminophen ... The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1529943022006829

a comparative effectiveness study Our findings suggest that IV acetaminophen is a safe and effective alternative to opioid use. The decrease in risk of side effects makes IV acetaminophen a ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538274/

Intravenous Acetaminophen for the Management of ... - NCBI IV acetaminophen can theoretically enhance bioavailability and provide an earlier onset of analgesic effect in the immediate post-operative period.

5. nysora.com nysora.com/education-news/no-analgesic-or-recovery-advantage-of-intravenous-over-oral-acetaminophen-in-ambulatory-lumbar-spine-surgery/

No analgesic or recovery advantage of intravenous over ... This study delivers valuable insights into the utility, limitations, and cost-effectiveness of IV acetaminophen in the outpatient surgical context. Methods.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07203079

Oral Versus Intravenous Acetaminophen in Lumbar Spine ... Also called a data safety and monitoring ... intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery.

7. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.909572/full

Efficacy and safety of intravenous acetaminophen (2 g/day) ... Our results suggest that intravenous acetaminophen at a daily dose of 2 g can reduce morphine consumption by Chinese adults within the first 24 h after ...

8. pharmacypractice.org pharmacypractice.org/index.php/pp/article/view/417

A retrospective analysis of intravenous acetaminophen use ... It appears IV APAP can be used effectively as an adjuvant pain management therapy in spinal surgery patients to decrease opioid exposure.