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

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).

Conditions

• Opioid Use
• Pain, Postoperative

Interventions

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)).

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.

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)).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Evan Kharasch, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-29

Primary Completion

2023-07-30

Completion

2024-01-30

FDA Drug

Yes

Countries

• United States

Study Locations