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

Phase 4

Completed

• Conditions: Opioid Use; Pain, Postoperative
• Interventions: Drug: Methadone; Drug: Fentanyl; Drug: Hydromorphone; Drug: Morphine; Drug: Sufentanil

• Registration Number: NCT03726268
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2018-11-29
• Primary Completion: 2023-07-30
• Status Verified: 2024-01
• Study Completion: 2024-01-30
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 907

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV methadone	Methadone	Intraoperative and post-operative IV methadone
IV fentanyl, sufentanil, morphine or hydromorphone	Fentanyl	Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
IV fentanyl, sufentanil, morphine or hydromorphone	Hydromorphone	Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
IV fentanyl, sufentanil, morphine or hydromorphone	Morphine	Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion
IV fentanyl, sufentanil, morphine or hydromorphone	Sufentanil	Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion

Primary Outcome Measures

Name	Time	Method
Total 30 day post-discharge home opioid use (number of tablets)	Approximately 30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States