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

NCT03726268 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Pro000899771R01DA042985-01
• Study Type: interventional
• Target: 907
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Opioid Use; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 30 days

Secondary Outcomes (4)

• Total Intraoperative Non-methadone Opioid Administration

  Approximately 12 hours

• Total Post Anesthesia Care Unit (PACU) Opioid Administration

  Approximately 2 hours

• Total Hospital Non-methadone Opioid Administration

  Start of surgery to hospital discharge, up to 2 days

• Total 7-day Post-PACU Discharge Home Opioid Use

  Up to 7 days post-PACU discharge

Study Arms (4)

Short-stay, IV methadone

ACTIVE COMPARATOR

Anticipated next-day discharge; intraoperative and post-operative IV methadone

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

Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil

Same-day, IV methadone

ACTIVE COMPARATOR

Intraoperative and post-operative IV methadone

Drug: Methadone

Same-day, IV short-acting opioids

ACTIVE COMPARATOR

Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion

Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil

Interventions

Methadone DRUG

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.

Same-day, IV methadone; Short-stay, IV methadone

Fentanyl DRUG

Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

Same-day, IV short-acting opioids; Short-stay, IV short-acting opioids

Hydromorphone DRUG

Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

Same-day, IV short-acting opioids; Short-stay, IV short-acting opioids

Morphine DRUG

Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

Same-day, IV short-acting opioids; Short-stay, IV short-acting opioids

Sufentanil DRUG

Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

Same-day, IV short-acting opioids; Short-stay, IV short-acting opioids

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years Undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of \< 24 hours
• Signed, written, informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Fentanyl; Hydromorphone; Morphine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Evan Kharasch, MD, PhD
• Organization: Duke University

evan.kharasch@duke.edu

919-613-1154

Study Officials

• Evan Kharasch, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: November 29, 2018
• Primary Completion: July 30, 2023
• Study Completion: January 30, 2024
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Locations

US (1)