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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

907 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Opioid Sparing Pain Management Strategy

NCT04269109

Cardiac Surgical Procedures

COMPLETED

Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery

NCT03034278

Opioid Use

COMPLETED

Preoperative Oral Methadone for Patients Undergoing Cardiac Surgery: Reduction of Postoperative Pain

NCT02774499

Pain

COMPLETED PHASE2

Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery

NCT06962306

Cleft Palate Pain Postoperative Care +2 more

RECRUITING PHASE4

Oral Methadone in Cardiac Surgery

NCT07221617

Pain, Postoperative Anesthesia Cardiac Surgery

RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Short-stay, IV methadone

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

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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.

Short-stay, IV short-acting opioids

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Hydromorphone

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Sufentanil

Intervention Type DRUG

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

Same-day, IV methadone

Intraoperative and post-operative IV methadone

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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.

Same-day, IV short-acting opioids

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Hydromorphone

Intervention Type DRUG

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

Morphine

Intervention Type DRUG

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

Sufentanil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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)).

Intervention Type 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)).

Intervention Type 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)).

Intervention Type 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)).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No