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Non-Opioid Pain Medication for Postoperative Pain (OSPREy Trial)
Phase 4
Waitlist Available
Led By Evan Kharasch, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of < 24 hours
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours
Awards & highlights
OSPREy Trial Summary
This trial is testing a new, non-opioid pain medication to see if it can help reduce pain after surgery while also reducing the amount of opioids consumed.
Who is the study for?
This trial is for adults aged 18-65 who are having outpatient surgery expected to cause moderate pain and require less than a day's hospital stay. They must understand and agree to the study terms. It's not for those with liver/kidney disease, pregnant/nursing women, or anyone using opioids daily.Check my eligibility
What is being tested?
The OSPREy-Outpatient Surgery Pain Relief Enhancement trial aims to refine pain management after surgery, reduce opioid use post-surgery, minimize side effects from opioids, and cut down on prescriptions that could lead to misuse.See study design
What are the potential side effects?
Opioids like Morphine, Sufentanil, Methadone, Fentanyl, and Hydromorphone can cause nausea, vomiting, constipation, drowsiness or sedation. There may also be risks of dependency or withdrawal symptoms.
OSPREy Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are between 18 and 65 years old and will have surgery with general anesthesia. Your surgery will be moderately painful, and you are expected to go home within 24 hours after the surgery.
OSPREy Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total 30 day post-discharge home opioid use (number of tablets)
Secondary outcome measures
Total 7d post-discharge home opioid use
Total PACU opioid administration
Total hospital non-methadone opioid administration
+1 moreOSPREy Trial Design
2Treatment groups
Active Control
Group I: IV methadoneActive Control1 Intervention
Intraoperative and post-operative IV methadone
Group II: IV fentanyl, sufentanil, morphine or hydromorphoneActive Control4 Interventions
Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,383 Previous Clinical Trials
3,426,704 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,622,149 Total Patients Enrolled
Evan Kharasch, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had liver or kidney disease in the past.You have been using strong painkillers like methadone, fentanyl patches, or a lot of oxycodone pills every day for a long time.You are between 18 and 65 years old and will have surgery with general anesthesia. Your surgery will be moderately painful, and you are expected to go home within 24 hours after the surgery.
Research Study Groups:
This trial has the following groups:- Group 1: IV methadone
- Group 2: IV fentanyl, sufentanil, morphine or hydromorphone
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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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