Optimizing Outpatient Anesthesia (OSPREy-Outpatient Surgery Pain Relief Enhancement)
Overview
- Phase
- Phase 4
- Intervention
- Hydromorphone
- Conditions
- Opioid Use
- Sponsor
- Duke University
- Enrollment
- 907
- Locations
- 1
- Primary Endpoint
- Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
Intervention: Hydromorphone
Short-stay, IV methadone
Anticipated next-day discharge; intraoperative and post-operative IV methadone
Intervention: Methadone
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
Intervention: Fentanyl
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
Intervention: Hydromorphone
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
Intervention: Morphine
Short-stay, IV short-acting opioids
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion
Intervention: Sufentanil
Same-day, IV methadone
Intraoperative and post-operative IV methadone
Intervention: Methadone
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
Intervention: Fentanyl
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
Intervention: Morphine
Same-day, IV short-acting opioids
Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion
Intervention: Sufentanil
Outcomes
Primary Outcomes
Total 30 Day Post-discharge Home Opioid Use (Number of Tablets)
Time Frame: Approximately 30 days
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.
Secondary Outcomes
- 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)