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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-operative weeks 1, 3, 5, and 8
Awards & highlights
Study 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.
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.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,474 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent are NSAID capsules a hazard for people seeking treatment?
"Although no efficacy data has been gathered, there are safety studies in place for NSAID capsules. Therefore, the assessment of its safety received a rating of 2 out of 3."
Answered by AI
Are there available slots in this experiment for participants?
"According to the data hosted on clinicaltrials.gov, enrollment is still open and this trial has been actively recruiting since its inception on December 27th 2021. The most recent update was also posted on that same day."
Answered by AI
What is the size of this medical research project's cohort?
"Affirmative. According to clinicaltrials.gov, this medical trial has been actively recruiting since December 27th 2021 and just recently underwent its last update on the same day. The study is seeking 121 patients from 1 site."
Answered by AI
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