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Non-Opioid Analgesic
Opioids vs Non-Opioids for Postoperative Pain After Knee Surgery
Phase 4
Recruiting
Led By Bruce Piatt, MD
Research Sponsored by Sanford Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, and 6 weeks post-operatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial will compare pain management with opioids versus non-opioids after knee surgery.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include gastrointestinal issues like bleeding or ulcers from Ibuprofen; liver damage from Acetaminophen; and addiction, drowsiness, constipation, nausea from Norco.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, and 6 weeks post-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, and 6 weeks post-operatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline Medication Use at 2 weeks
Pain
Secondary study objectives
Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: OpioidActive Control1 Intervention
Group II: Non-opioidActive Control2 Interventions
Find a Location
Who is running the clinical trial?
Sanford HealthLead Sponsor
50 Previous Clinical Trials
66,803 Total Patients Enrolled
Bruce Piatt, MDPrincipal InvestigatorSanford Health
1 Previous Clinical Trials
1 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.You have a known or suspected problem with using drugs or alcohol.You have a problem with drinking too much alcohol.I have an active peptic ulcer or severe heartburn.I have chosen not to participate in this trial.I am showing signs of an infection.You have a history of using strong painkillers for a long time.I am scheduled for knee surgery to remove or repair damaged tissue or loose fragments.I am between 18 and 80 years old.I have had knee surgery on both knees.I haven't had major health issues like heart problems or liver disease in the past year.I am not allergic to hydrocodone, acetaminophen, or ibuprofen.I understand the study's requirements and am willing to sign the consent form.I am currently on blood thinners, except for low-dose aspirin.
Research Study Groups:
This trial has the following groups:- Group 1: Opioid
- Group 2: Non-opioid
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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