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Non-narcotic Analgesic
Ibuprofen & Acetaminophen vs Oxycodone for Postoperative Pain
Phase 2
Recruiting
Led By Amy Ladd, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing trapeziectomy for thumb osteoarthritis
Be older than 18 years old
Must not have
Liver or kidney dysfunction, abnormal liver enzymes restricting use of acetaminophen or ibuprofen
Current use of opioids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-operative weeks 1, 3, 5, and 8
Awards & highlights
Summary
This trial found that a combination of over the counter NSAIDs was as effective as the prescription opioid oxycodone for pain management in the first month after surgery for thumb osteoarthritis.
Who is the study for?
This trial is for English-speaking individuals undergoing trapeziectomy due to thumb osteoarthritis. It's not suitable for those with concurrent surgeries, liver/kidney issues, allergies to the study medications, pregnant women, people unable to complete forms due to various conditions, or patients with a history of heart failure, bleeding disorders or current opioid use.Check my eligibility
What is being tested?
The study compares pain management strategies post-trapeziectomy: one group receives NSAIDs (ibuprofen and acetaminophen) while the other gets an opioid (oxycodone). The goal is to assess if non-narcotic meds can effectively manage pain without using opioids in the first month after surgery.See study design
What are the potential side effects?
NSAIDs may cause stomach upset, bleeding risks and kidney problems. Oxycodone can lead to constipation, nausea/vomiting, drowsiness and has a high risk of addiction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery for thumb arthritis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use common pain relievers due to liver or kidney issues.
Select...
I am currently using opioids.
Select...
I have a history of complex regional pain syndrome.
Select...
I am having or have had multiple surgeries at the same time.
Select...
I have a history of heart failure, stomach bleeding, or blood clotting issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-operative weeks 1, 3, 5, and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-operative weeks 1, 3, 5, and 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain
Pain
Pharmaceutical Preparations
+1 moreSecondary outcome measures
Change in PROMIS-PI scores over time
Change in Quick DASH scores over time
Trial Design
2Treatment groups
Experimental Treatment
Group I: OpioidsExperimental Treatment1 Intervention
Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.
Group II: NSAIDSExperimental Treatment1 Intervention
Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,818 Total Patients Enrolled
7 Trials studying Postoperative Pain
1,042 Patients Enrolled for Postoperative Pain
Amy Ladd, MDPrincipal InvestigatorStanford Orthopaedic Surgery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use common pain relievers due to liver or kidney issues.I am currently using opioids.I have a history of complex regional pain syndrome.I am having or have had multiple surgeries at the same time.You are allergic or intolerant to Ibuprofen, Acetaminophen, or Oxycodone.I have a history of heart failure, stomach bleeding, or blood clotting issues.I am having surgery for thumb arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Opioids
- Group 2: NSAIDS
Awards:
This trial has 1 awards, including:- 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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