Phase 4
N=786
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Opioid Use · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03726268 ↗Enrolled (actual)
786
Serious AEs
4.2%
Results posted
Nov 2025
Primary outcome: Primary: Total 30 Day Post-discharge Home Opioid Use (Number of Tablets) — 10.00; 10.00; 6.18; 6.67 tablets — p=0.970
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Fentanyl (Drug); Hydromorphone (Drug); Morphine (Drug); Sufentanil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total 30 Day Post-discharge Home Opioid Use (Number of Tablets) |
10.00; 10.00; 6.18; 6.67 | 0.970 |
| SECONDARY Total Intraoperative Non-methadone Opioid Administration |
0.0; 18.0; 0.0; 16.7 | <0.001 sig |
| SECONDARY Total Post Anesthesia Care Unit (PACU) Opioid Administration |
2.0; 3.0; 2.0; 2.5 | <0.001 sig |
| SECONDARY Total Hospital Non-methadone Opioid Administration |
30; 128; 0; 68 | <0.001 sig |
| SECONDARY Total 7-day Post-PACU Discharge Home Opioid Use |
6.50; 8.20; 4.96; 5.45 | 0.105 |
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).
Eligibility Criteria
Inclusion Criteria
- Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of < 24 hours
- Signed, written, informed consent
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03726268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.