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

Pain, Postoperative Clinical Trial

— OSPREy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726268
• Other study ID #: Pro00089977
• Secondary ID: 1R01DA042985-01
• Status: Completed
• Phase: Phase 4
• Start date: November 29, 2018
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 907
• Est. completion date: January 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative

Intervention

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.
• Fentanyl
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
• Hydromorphone
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
• Morphine
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
• Sufentanil
Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total 30 day post-discharge home opioid use (number of tablets)		Approximately 30 days
Secondary	Total intraoperative non-methadone opioid administration		Approximately 12 hours
Secondary	Total PACU opioid administration		Approximately 2 hours
Secondary	Total hospital non-methadone opioid administration		Up to 72 hours
Secondary	Total 7d post-discharge home opioid use		Up to 7 days