Opioid UsePhase 4OSPREyNCT03726268
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
A Phase 4 study testing Methadone, Fentanyl and Hydromorphone in people with Opioid Use and Pain, Postoperative, run by Duke University at 1 site in United States.
Trial summary
The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Pain, Postoperative
- What is being tested?
- Methadone, Fentanyl and Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 907 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 30 Jan 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of < 24 hours
- Signed, written, informed consent
Who cannot join
- History of liver or kidney disease.
- Females who are pregnant or nursing.
- Chronic opioid use (e.g. preoperative daily use of methadone, fentanyl transdermal patches, or ≥ 3 oxycodone pills)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).
Read the detailed description
This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day discharge surgery (compare short-duration vs long-duration opioid).
- Conditions
- Opioid Use, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients.
FentanylDrug
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
HydromorphoneDrug
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
MorphineDrug
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
SufentanilDrug
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
| Study group | Role | What they receive |
|---|---|---|
| Short-stay, IV methadone | Active comparator | Anticipated next-day discharge; intraoperative and post-operative IV methadone Receives: Drug: Methadone |
| Short-stay, IV short-acting opioids | Active comparator | Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Receives: Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil |
| Same-day, IV methadone | Active comparator | Intraoperative and post-operative IV methadone Receives: Drug: Methadone |
| Same-day, IV short-acting opioids | Active comparator | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Receives: Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)
Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects.
Measured: Approximately 30 days
Secondary outcomes (4)
Total Intraoperative Non-methadone Opioid Administration
Based on hospital record.
Measured: Approximately 12 hours
Total Post Anesthesia Care Unit (PACU) Opioid Administration
Based on hospital record.
Measured: Approximately 2 hours
Total Hospital Non-methadone Opioid Administration
Based on hospital record.
Measured: Start of surgery to hospital discharge, up to 2 days
Total 7-day Post-PACU Discharge Home Opioid Use
Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects.
Measured: Up to 7 days post-PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start29 Nov 2018
- Primary completion30 Jul 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Evan Kharasch, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726268
- Sponsor's protocol ID
- Pro00089977
- Other IDs
- 1R01DA042985-01
- Acronym
- OSPREy
- Status last verified
- Nov 2025
- First submitted
- 29 Oct 2018
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kharasch ED, Schlabaugh C, Metzler E, Schultz A. Coronavirus Disease-2019 Pandemic Effects on Patient Decisions Regarding Clinical Trial Participation. Anesth Analg. 2024 Apr 1;138(4):906-908. doi: 10.1213/ANE.0000000000006783. Epub 2024 Mar 15. No abstract available.
PubMed 38447097