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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours for reporting.

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 more

OSPREy 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

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,419,315 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,618,216 Total Patients Enrolled
Evan Kharasch, MDPrincipal InvestigatorDuke University

Media Library

IV methadone Clinical Trial Eligibility Overview. Trial Name: NCT03726268 — Phase 4
Opioid Use Disorder Research Study Groups: IV methadone, IV fentanyl, sufentanil, morphine or hydromorphone
Opioid Use Disorder Clinical Trial 2023: IV methadone Highlights & Side Effects. Trial Name: NCT03726268 — Phase 4
IV methadone 2023 Treatment Timeline for Medical Study. Trial Name: NCT03726268 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks come with injecting fentanyl, sufentanil, morphine or hydromorphone?

"Given the Phase 4 status, which signifies approval of this treatment, our team at Power regarded IV fentanyl, sufentanil, morphine or hydromorphone's safety with a score of 3."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, originally posted on November 29th 2018, is searching for 1000 participants from a singular medical centre. The information available was most recently updated August 23rd 2022."

Answered by AI

Does the criteria for this clinical trial include participants under 30 years old?

"This trial has specified a patient age range of 18 to 65 in order to qualify for inclusion. There are 100 studies available for those younger than 18 and 541 for individuals who have passed the retirement milestone."

Answered by AI

Are there any vacancies for individuals to take part in this clinical trial?

"Clinicaltrials.gov has reported that this study is actively enrolling participants, with the original posting date being November 29th 2018 and its most recent update occurring on August 23rd 2022."

Answered by AI

For what medical purposes are IV fentanyl, sufentanil, morphine or hydromorphone typically used?

"IV fentanyl, sufentanil, morphine and hydromorphone are often administered to patients under general anesthesia. These drugs can also serve as effective solutions for the amelioration of neuropathic pain, certain medical procedures, and induction anesthetic therapy."

Answered by AI

Who is qualified to participate in this research study?

"This research trial seeks 1000 individuals suffering pain post-surgery, aged between 18 and 65. Furthermore, those hoping to enrol need to have undergone general anesthesia during their operation; they should anticipate a stay at the medical centre of less than 24 hours; and must provide their written consent."

Answered by AI

What previous research has been conducted regarding the utilization of IV fentanyl, sufentanil, morphine or hydromorphone?

"Presently, 115 active studies are investigating IV fentanyl, sufentanil, morphine or hydromorphone. Of these trials, 28 have been classified as Phase 3. The bulk of the experiments for this drug class are situated in Boston; however 239 locations worldwide host such research initiatives."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
2018. "Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03726268.
~143 spots leftby Apr 2025
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