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

Duke University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Opioid Use

Treatments: Drug: Morphine; Drug: Methadone; Drug: Hydromorphone; Drug: Fentanyl; Drug: Sufentanil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03726268

Pro00089977

1R01DA042985-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 907 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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907 participants in 4 patient groups

Short-stay, IV methadone

Active Comparator group

Description:

Anticipated next-day discharge; intraoperative and post-operative IV methadone

Treatment:

Drug: Methadone

Short-stay, IV short-acting opioids

Active Comparator group

Description:

Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion

Treatment:

Drug: Sufentanil

Drug: Fentanyl

Drug: Hydromorphone

Drug: Morphine

Same-day, IV methadone

Active Comparator group

Description:

Intraoperative and post-operative IV methadone

Treatment:

Drug: Methadone

Same-day, IV short-acting opioids

Active Comparator group

Description:

Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion

Treatment:

Drug: Sufentanil

Drug: Fentanyl

Drug: Hydromorphone

Drug: Morphine