Acetaminophen for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of acetaminophen for pain relief after lumbar spine fusion surgery. Researchers aim to determine whether oral acetaminophen is more effective than IV administration. Participants will receive either oral acetaminophen or an IV infusion for two days post-surgery. The study seeks individuals scheduled for lumbar spine fusion surgery who can swallow pills and have no medical contraindications to acetaminophen. As a Phase 4 trial, this research explores how this FDA-approved and effective treatment can benefit more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for acetaminophen?
A previous study found that taking acetaminophen orally reduced the need for opioids after surgery, suggesting it is well-tolerated, as fewer opioids lead to fewer side effects. Another study demonstrated that a single dose of oral acetaminophen provided effective pain relief for many patients for about four hours post-surgery.
Research has also shown that acetaminophen administered through an IV is safe and effective. One study found that patients receiving IV acetaminophen experienced less post-surgical pain and required fewer additional pain medications. Another study indicated that using IV acetaminophen helped shorten hospital stays by reducing opioid use.
Both oral and IV acetaminophen have been shown to control pain after surgery without major safety concerns, supported by their common use and approval for pain management.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about acetaminophen for postoperative pain because it offers versatile administration options that can be tailored to patient needs. Unlike typical pain medications that might rely heavily on opioids, acetaminophen provides an alternative with fewer side effects and lower dependency risks. This trial compares oral and intravenous delivery methods, offering flexibility and potentially faster pain relief through intravenous administration. This variety in administration could enhance patient comfort and pain management following spine surgery, setting acetaminophen apart from the standard opioid-based care.
What is the effectiveness track record for acetaminophen in treating postoperative pain?
This trial will compare the effectiveness of oral and intravenous acetaminophen in managing postoperative pain. Studies have shown that both forms effectively manage pain after surgery. A single dose of oral acetaminophen relieves pain for about half of the patients for around four hours and reduces the need for stronger painkillers, like opioids, while lessening postoperative nausea. Research indicates that intravenous acetaminophen improves pain relief and further reduces opioid use, enhancing patient comfort after surgery. Comparisons between oral and intravenous forms suggest they offer similar pain relief. Overall, acetaminophen is a reliable option for controlling postoperative pain.14678
Who Is on the Research Team?
Atman Desai, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for patients undergoing lumbar spine fusion surgery who need pain control. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that would interfere with the study or pose a risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oral or intravenous acetaminophen for 48 hours post-surgery
Postoperative Monitoring
Participants are monitored for pain intensity and opioid consumption until discharge
Follow-up
Participants' quality of life and any treatment-related adverse effects are assessed
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
Trial Overview
The study is testing the effectiveness of oral versus intravenous acetaminophen in managing postoperative pain after lumbar spine surgery. It includes a placebo group for each administration method to compare results.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery
Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Citations
A literature review of randomized clinical trials ...
Twelve of the 14 placebo studies found that IV acetaminophen patients had improved analgesia. Ten of those 14 studies reported less opioid consumption, a lower ...
The Effect of Intravenous Paracetamol on Postoperative Pain ...
In fact, their study also showed that intravenous paracetamol not only effectively reduced postoperative pain severity but also increased patients' ...
Systematic Review and Meta-Analysis of Randomized ...
Several lines of evidence have demonstrated that intravenous acetaminophen reduces the opioid requirement and increases the postoperative comfort level.12,13 ...
4.
cochrane.org
cochrane.org/evidence/CD007126_intravenous-paracetamol-acetaminophen-pain-after-surgery-adults-and-childrenIntravenous paracetamol (acetaminophen) for pain after ...
We found high quality evidence that IV paracetamol or IV propacetamol provided pain relief for four hours for about 36% of people versus 16% of ...
Effectiveness of oral vs intravenous acetaminophen on ...
The results demonstrated that oral acetaminophen was comparable to intravenous acetaminophen with regard to VAS scores at 24 h and 48 h (P = ...
Effect of the intravenous acetaminophen clinical pathway ...
Effect of the intravenous acetaminophen clinical pathway on postoperative analgesia in spinal fusion surgery.
Efficacy and safety of intravenous acetaminophen (2 g/day) ...
We have demonstrated that intravenous administration of 500 mg acetaminophen every 6 h in 24 h postoperatively reduced the supplemental intravenous morphine ...
Estimating the Effect of Intravenous Acetaminophen for ...
This investigation indicates that reducing opioid use and including IV APAP for postoperative pain management has the potential to decrease LOS, ...
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