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Trial · NCT03726268

Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)

NCT03726268, Phase 4, Completed, Duke University; results first posted 2025-11-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement). Trials, record NCT03726268. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03726268

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
NCT number
NCT03726268
Status
Completed
Phases
Phase 4
Enrollment
907 participants, actual
Lead sponsor
Duke University
Conditions
Opioid Use, Pain, Postoperative
Interventions
Methadone, Fentanyl, Hydromorphone, Morphine, Sufentanil
First posted
2018-10-31
Last updated
2025-11-19
Results first posted
2025-11-19

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTotal 30 Day Post-discharge Home Opioid Use (Number of Tablets)Approximately 30 days
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.
SecondaryTotal Intraoperative Non-methadone Opioid AdministrationApproximately 12 hoursBased on hospital record.
SecondaryTotal Post Anesthesia Care Unit (PACU) Opioid AdministrationApproximately 2 hoursBased on hospital record.
SecondaryTotal Hospital Non-methadone Opioid AdministrationStart of surgery to hospital discharge, up to 2 daysBased on hospital record.
SecondaryTotal 7-day Post-PACU Discharge Home Opioid UseUp to 7 days post-PACU discharge
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.

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTotal 30 Day Post-discharge Home Opioid Use (Number of Tablets)Approximately 30 daystabletsMEAN
SECONDARYTotal Intraoperative Non-methadone Opioid AdministrationApproximately 12 hoursMilligram Morphine Equivalent (MME)MEDIAN
SECONDARYTotal Post Anesthesia Care Unit (PACU) Opioid AdministrationApproximately 2 hoursMilligram Morphine Equivalent (MME)MEDIAN
SECONDARYTotal Hospital Non-methadone Opioid AdministrationStart of surgery to hospital discharge, up to 2 daysMilligram Morphine Equivalent (MME)MEDIAN
SECONDARYTotal 7-day Post-PACU Discharge Home Opioid UseUp to 7 days post-PACU dischargeParticipants with data collected.tabletsMEAN

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)Short-stay, IV Methadone10.00Standard Deviation 15.50tablets
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)Short-stay, IV Short-acting Opioids10.00Standard Deviation 11.60tablets
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)Same-day, IV Methadone6.18Standard Deviation 8.40tablets
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)Same-day, IV Short-acting Opioids6.67Standard Deviation 10.40tablets
Total Intraoperative Non-methadone Opioid AdministrationShort-stay, IV Methadone0.0Inter-Quartile Range 0.0 to 0.0Milligram Morphine Equivalent (MME)
Total Intraoperative Non-methadone Opioid AdministrationShort-stay, IV Short-acting Opioids18.0Inter-Quartile Range 14.0 to 23.0Milligram Morphine Equivalent (MME)
Total Intraoperative Non-methadone Opioid AdministrationSame-day, IV Methadone0.0Inter-Quartile Range 0.0 to 0.0Milligram Morphine Equivalent (MME)
Total Intraoperative Non-methadone Opioid AdministrationSame-day, IV Short-acting Opioids16.7Inter-Quartile Range 12.7 to 24.0Milligram Morphine Equivalent (MME)
Total Post Anesthesia Care Unit (PACU) Opioid AdministrationShort-stay, IV Methadone2.0Inter-Quartile Range 0 to 4.0Milligram Morphine Equivalent (MME)
Total Post Anesthesia Care Unit (PACU) Opioid AdministrationShort-stay, IV Short-acting Opioids3.0Inter-Quartile Range 0.0 to 7.0Milligram Morphine Equivalent (MME)

Participant flow12

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDShort-stay, IV Methadone188
Overall StudySTARTEDShort-stay, IV Short-acting Opioids188
Overall StudySTARTEDSame-day, IV Methadone205
Overall StudySTARTEDSame-day, IV Short-acting Opioids205
Overall StudyCOMPLETEDShort-stay, IV Methadone175
Overall StudyCOMPLETEDShort-stay, IV Short-acting Opioids175
Overall StudyCOMPLETEDSame-day, IV Methadone190
Overall StudyCOMPLETEDSame-day, IV Short-acting Opioids194
Overall StudyNOT COMPLETEDShort-stay, IV Methadone13
Overall StudyNOT COMPLETEDShort-stay, IV Short-acting Opioids13

Adverse events356

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCOVIDRespiratory, thoracic and mediastinal disordersShort-stay, IV Methadone1188
otherCOVIDRespiratory, thoracic and mediastinal disordersShort-stay, IV Short-acting Opioids0188
otherCOVIDRespiratory, thoracic and mediastinal disordersSame-day, IV Methadone1205
otherCOVIDRespiratory, thoracic and mediastinal disordersSame-day, IV Short-acting Opioids2205
otherDVTVascular disordersShort-stay, IV Methadone1188
otherDVTVascular disordersShort-stay, IV Short-acting Opioids1188
otherDVTVascular disordersSame-day, IV Methadone1205
otherDVTVascular disordersSame-day, IV Short-acting Opioids0205
otherabdominal distensionGastrointestinal disordersShort-stay, IV Methadone0188
otherabdominal distensionGastrointestinal disordersShort-stay, IV Short-acting Opioids2188

Adverse event totals12

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityShort-stay, IV Methadone0188
Total, all-cause mortalityShort-stay, IV Short-acting Opioids1188
Total, all-cause mortalitySame-day, IV Methadone0205
Total, all-cause mortalitySame-day, IV Short-acting Opioids0205
Total, other adverse eventsShort-stay, IV Methadone21188
Total, other adverse eventsShort-stay, IV Short-acting Opioids17188
Total, other adverse eventsSame-day, IV Methadone29205
Total, other adverse eventsSame-day, IV Short-acting Opioids16205
Total, serious adverse eventsShort-stay, IV Methadone6188
Total, serious adverse eventsShort-stay, IV Short-acting Opioids6188

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
38447097DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DA042985OPTIMIZING OUTPATIENT ANESTHESIA: IMPROVING ANALGESIA AND REDUCING OPIOID MISADVENTUREKHARASCH, EVAN D.DUKE UNIVERSITYNATIONAL INSTITUTE ON DRUG ABUSE2017 to 2021

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03726268

GET https://conductscience.org/api/trials/v1/NCT03726268/events?page=2