148 Participants Needed

Opioids vs Non-Opioids for Postoperative Pain After Knee Surgery

AT
KJ
Overseen ByKatie Jensen
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

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.

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 certain blood thinners or medications that increase bleeding, except for low-dose aspirin (ASA 81mg).

Is it safe to use opioids and non-opioids like acetaminophen and ibuprofen for postoperative pain after knee surgery?

Acetaminophen (also known as paracetamol) and ibuprofen are generally considered safe for managing postoperative pain, with acetaminophen having a particularly safe profile. Combining these with opioids can reduce the amount of opioids needed, potentially lowering the risk of opioid-related side effects.12345

How does the drug acetaminophen and ibuprofen differ from other treatments for postoperative pain after knee surgery?

Acetaminophen and ibuprofen are non-opioid pain relievers that can reduce the need for opioids, which are often used for postoperative pain but can have significant side effects. This combination is part of a multimodal approach to pain management, offering a safer profile and potentially fewer side effects compared to opioid-only treatments.34678

What data supports the effectiveness of the drug for postoperative pain after knee surgery?

Research shows that acetaminophen (paracetamol) is effective for treating postsurgical pain and is often used in combination with opioids to enhance pain relief and reduce opioid side effects. Additionally, ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), has been shown to provide significant pain relief, with a lower number of patients needed to treat compared to paracetamol alone.13456

Who Is on the Research Team?

BP

Bruce Piatt, MD

Principal Investigator

Sanford Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 undergoing elective knee arthroscopy, like meniscectomy or loose body removal. It's not for those with a history of chronic opioid use, significant medical issues in the past year, pregnant/nursing women, or anyone unable to consent. People on certain blood thinners or with active ulcers are also excluded.

Inclusion Criteria

I am scheduled for knee surgery to remove or repair damaged tissue or loose fragments.

Exclusion Criteria

I have been diagnosed with cognitive impairment.
I am scheduled for knee ligament reconstruction surgery.
I have chronic pain that lasts a long time.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either opioid or non-opioid medications for pain management after knee arthroscopy

6 weeks
Daily monitoring for 2 weeks, follow-up at 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Follow-up assessments at 2 weeks and 6 weeks post-operatively

What Are the Treatments Tested in This Trial?

Interventions

  • Acetaminophen 325Mg Tab
  • Ibuprofen 600 mg
  • Norco 5Mg-325Mg Tablet
Trial Overview The study compares pain management using opioids (Norco) versus non-opioids (Ibuprofen and Acetaminophen) after knee surgery. It aims to see if non-narcotics can match narcotics' pain relief and how patient characteristics influence post-surgery pain and medication effectiveness.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: OpioidActive Control1 Intervention
Group II: Non-opioidActive Control2 Interventions

Acetaminophen 325Mg Tab is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as Tylenol for:
  • Pain relief
  • Fever reduction
🇪🇺
Approved in European Union as Paracetamol for:
  • Pain relief
  • Fever reduction
🇨🇦
Approved in Canada as Acetaminophen for:
  • Pain relief
  • Fever reduction
🇯🇵
Approved in Japan as Paracetamol for:
  • Pain relief
  • Fever reduction
🇨🇳
Approved in China as Paracetamol for:
  • Pain relief
  • Fever reduction
🇨🇭
Approved in Switzerland as Paracetamol for:
  • Pain relief
  • Fever reduction

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanford Health

Lead Sponsor

Trials
53
Recruited
2,067,000+

Published Research Related to This Trial

Multimechanistic approaches to postoperative pain relief, including the use of acetaminophen, can improve pain management, reduce the need for opioids, and lower the risk of opioid-related side effects, enhancing overall surgical outcomes.
Oral acetaminophen, especially when combined with opioids, has been shown to be safe and effective for managing postsurgical pain, and transitioning from intravenous to oral formulations is a reasonable strategy for continued pain control.
Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations.Pergolizzi, JV., Raffa, RB., Tallarida, R., et al.[2013]
In a study of 64 knee arthroplasty patients, ketoprofen significantly reduced the need for oxycodone pain relief during the first day after surgery, demonstrating its opioid-sparing effect.
After the first day, diclofenac was more effective than placebo in managing pain, while ketoprofen did not show the same level of efficacy beyond the initial postoperative period.
Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty.Silvanto, M., Lappi, M., Rosenberg, PH.[2019]
Paracetamol (1000 mg) is effective for postoperative pain relief, achieving at least 50% pain relief in patients with a number-needed-to-treat (NNT) of 4.6 compared to placebo, based on a review of 40 trials involving 4171 patients.
Combining paracetamol with codeine (60 mg) enhances pain relief, with an NNT of 3.6 for achieving at least 50% pain relief, but this combination may increase the risk of drowsiness and dizziness, indicating a trade-off between efficacy and potential side effects.
Single dose paracetamol (acetaminophen), with and without codeine, for postoperative pain.Moore, A., Collins, S., Carroll, D., et al.[2020]

Citations

Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations. [2013]
Comparison of the opioid-sparing efficacy of diclofenac and ketoprofen for 3 days after knee arthroplasty. [2019]
Single dose paracetamol (acetaminophen), with and without codeine, for postoperative pain. [2020]
[Pharmacotherapy of postoperative pain]. [2013]
Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]
Clinical evaluation of intravenous paracetamol versus Parecoxib for postoperative analgesia after general anaesthesia. [2020]
Post-operative analgesic effects of paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review. [2022]
Intravenous non-opioid analgesia for peri- and postoperative pain management: a scientific review of intravenous acetaminophen and ibuprofen. [2022]
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