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

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).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use
• Intervention / Treatment: Drug: Methadone; Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil

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).

• Study Type: Interventional
• Enrollment (Actual): 907
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Evan Kharasch, MD; Phone Number: 919-613-1154; Email: katelynne.durrant@duke.edu
• Study Contact Backup: Name: Alicja Szydlowska, MBA; Phone Number: 919-681-4377; Email: alicja.szydlowska@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 (10 mg if ≤55kg), 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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total 30 day post-discharge home opioid use (number of tablets)	Approximately 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Total intraoperative non-methadone opioid administration	Approximately 12 hours
Total PACU opioid administration	Approximately 2 hours
Total hospital non-methadone opioid administration	Up to 72 hours
Total 7d post-discharge home opioid use	Up to 7 days

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Evan Kharasch, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Respiratory System Agents; Antitussive Agents; Fentanyl; Morphine; Sufentanil; Hydromorphone; Methadone
• Other Study ID Numbers: Pro00089977; 1R01DA042985-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• 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