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

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ClinicalTrials.gov Identifier: NCT03726268
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

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).

Condition or disease Intervention/treatment Phase
Opioid Use Pain, Postoperative Drug: Methadone Drug: Fentanyl Drug: Hydromorphone Drug: Morphine Drug: Sufentanil Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Active Comparator: IV methadone
Intraoperative and post-operative IV methadone
Drug: Methadone
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 and 10 mg in "same-day" surgery patients.

Active Comparator: IV fentanyl, sufentanil, morphine or hydromorphone
Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
Drug: Fentanyl
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

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

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

Drug: Sufentanil
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 Measures :
  1. Total 30 day post-discharge home opioid use (number of tablets) [ Time Frame: Approximately 30 days ]

Secondary Outcome Measures :
  1. Total intraoperative non-methadone opioid administration [ Time Frame: Approximately 12 hours ]
  2. Total PACU opioid administration [ Time Frame: Approximately 2 hours ]
  3. Total hospital non-methadone opioid administration [ Time Frame: Up to 72 hours ]
  4. Total 7d post-discharge home opioid use [ Time Frame: Up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726268


Contacts
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Contact: Evan Kharasch, MD 919-613-1154 katelynne.durrant@duke.edu
Contact: Alicja Szydlowska, MBA 919-681-4377 alicja.szydlowska@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Alicja Szydlowska, MBA         
Contact       alicja.szydlowska@duke.edu   
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Evan Kharasch, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03726268     History of Changes
Other Study ID Numbers: Pro00089977
1R01DA042985-01 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Sufentanil
Morphine
Methadone
Hydromorphone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Antitussive Agents
Respiratory System Agents