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Opioid Analgesic
Pain Medication for Postoperative Pain
Phase 3
Recruiting
Led By David Greenberg, MD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Femoral Shaft or Neck bone lesion
18 years old or greater
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to six weeks post-op
Awards & highlights
Study Summary
This trial looks at the effects of post-operative pain medication on patients who have had a prophylactic intramedullary femoral nail placed.
Who is the study for?
This trial is for adults planning to undergo prophylactic intramedullary nailing of the femur due to bone lesions. It's not suitable for those with coagulation disorders, current fractures, severe kidney or liver disease, peptic ulcer disease, certain heart conditions, allergies to acetaminophen or NSAIDs, opioid addiction or dependence, pregnancy, and those on specific medications like probenecid.Check my eligibility
What is being tested?
The study investigates the effectiveness of using a pain reliever called Toradol in combination with opioids versus just opioids alone after surgery for securing weak bones in patients without fractures. The goal is to see if adding an NSAID can help manage post-op pain without affecting healing.See study design
What are the potential side effects?
Possible side effects include risk of bleeding from Toradol (an NSAID), stomach ulcers, kidney problems; and from opioids: drowsiness, constipation, nausea/vomiting and potential dependency issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a bone lesion in my femur.
Select...
I am 18 years old or older.
Select...
I am planning to have surgery to prevent fractures in my thigh bone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to six weeks post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to six weeks post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Milligram Morphine Equivalent (MME) of Opioid Medications Utilized
Secondary outcome measures
Numerical Rating Scale (NRS)
Patient Reported Outcomes Measurement System (PROMIS) Pain Intensity Scale
Single Assessment Numerical Evaluation (SANE)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental ArmExperimental Treatment6 Interventions
For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.
Group II: ControlPlacebo Group6 Interventions
Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone Acetaminophen
2017
Completed Phase 3
~180
Hydrocodone/Acetaminophen
2020
Completed Phase 4
~300
Ketorolac
2014
Completed Phase 4
~1760
Morphine
2013
Completed Phase 4
~2230
Acetaminophen
2017
Completed Phase 4
~2030
Oxycodone
2014
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,595 Total Patients Enrolled
David Greenberg, MDPrincipal Investigator - St. Louis University
St. Louis University Hospital
Georgetown University School Of Medicine (Medical School)
University Mo-Columbia School Medicine (Residency)
1 Previous Clinical Trials
38 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of depending too much on or misusing opioid medications.I have a bone lesion in my femur.You are allergic to opioids and cannot use them.You are allergic to acetaminophen.I have had peptic ulcer disease in the past.I have a history of heart failure or heart disease.I have had heart bypass surgery.I am on chemotherapy that doesn't allow for NSAID use.I am 18 years old or older.I have a fracture caused by my cancer.You have had an allergic reaction to NSAIDs or aspirin in the past.I cannot use toradol due to my liver condition.I am currently taking the medication probenecid.I have had severe kidney problems in the past.I have a blood clotting disorder or need blood-thinning medication during the study.I am planning to have surgery to prevent fractures in my thigh bone.I am currently taking Pentoxifylline.You have had asthma caused by taking aspirin.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What afflictions does Oxycodone Acetaminophen commonly relieve?
"Oxycodone Acetaminophen is frequently used to help with pupil dilation. However, it has also been taken to mitigate conditions like catarrh, rhinorrhoea, and musculoskeletal pain."
Answered by AI
Are there harmful effects of Oxycodone Acetaminophen if misused?
"There is some efficacy data and multiple rounds of safety data, making Oxycodone Acetaminophen a 3 on our safety scale."
Answered by AI
What other scholarly papers have been published on Oxycodone Acetaminophen?
"As of now, there are a total of 199 ongoing trials for Oxycodone Acetaminophen with 51 of those trials being in Phase 3. Boston, Massachusetts has a significant amount of these studies, but in total, there are 1189 locations running these trials."
Answered by AI
How many participants are recruited for this clinical trial?
"That is correct. The information available on clinicaltrials.gov supports that this research study is still actively looking for patients. The details of the posting indicate that the trial was first advertised on February 20th, 2019 and was last updated on December 2nd, 2021. They are seeking a total of 60 individuals from 1 location."
Answered by AI
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