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

Primary Purpose

Opioid Use, Pain, Postoperative

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methadone
Fentanyl
Hydromorphone
Morphine
Sufentanil
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IV methadone

IV fentanyl, sufentanil, morphine or hydromorphone

Arm Description

Intraoperative and post-operative IV methadone

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

Outcomes

Primary Outcome Measures

Total 30 day post-discharge home opioid use (number of tablets)

Secondary Outcome Measures

Total intraoperative non-methadone opioid administration
Total PACU opioid administration
Total hospital non-methadone opioid administration
Total 7d post-discharge home opioid use

Full Information

First Posted
October 29, 2018
Last Updated
August 16, 2023
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03726268
Brief Title
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Acronym
OSPREy
Official Title
Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV methadone
Arm Type
Active Comparator
Arm Description
Intraoperative and post-operative IV methadone
Arm Title
IV fentanyl, sufentanil, morphine or hydromorphone
Arm Type
Active Comparator
Arm Description
Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Intervention Description
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
Primary Outcome Measure Information:
Title
Total 30 day post-discharge home opioid use (number of tablets)
Time Frame
Approximately 30 days
Secondary Outcome Measure Information:
Title
Total intraoperative non-methadone opioid administration
Time Frame
Approximately 12 hours
Title
Total PACU opioid administration
Time Frame
Approximately 2 hours
Title
Total hospital non-methadone opioid administration
Time Frame
Up to 72 hours
Title
Total 7d post-discharge home opioid use
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Kharasch, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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