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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Opioid Use, Pain, Postoperative

Intervention / Treatment
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* Drug: Methadone
* Drug: Fentanyl
* Drug: Hydromorphone
* Drug: Morphine
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IV methadone<br>Intraoperative and post-operative IV methadone | Drug: Methadone<br>* 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.<br>|
| Active Comparator: IV fentanyl, sufentanil, morphine or hydromorphone<br>Intraoperative and post-operative IV fentanyl, morphine or hydromorphone at anesthesia provider discretion | Drug: Fentanyl<br>* Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).<br>Drug: Hydromorphone<br>* Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).<br>Drug: Morphine<br>* Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).<br>Drug: Sufentanil<br>* Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |