Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

NCT ID: NCT04387136

Last Updated: 2022-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2021-02-04

Brief Summary

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The purpose of this study is to determine if a single dose of sublingual sufentanil given 15-30 minutes prior to wake up is efficacious at reducing recovery room time.

Detailed Description

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This is a level I randomized prospective outcomes study comparing two groups of patients. Within 15-30 minutes of planned wake-up Group 1 will receive 30 mcg of sublingual sufentanil and group 2 will not receive sublingual sufentanil.

Conditions

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Pain Pain, Acute Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sublingual Sufentanil

Participants in this arm will receive the intervention.

Group Type EXPERIMENTAL

Sublingual Sufentanil

Intervention Type DRUG

15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.

Control

Participants in this arm will not receive an intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sublingual Sufentanil

15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.

Intervention Type DRUG

Other Intervention Names

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Dsuvia Sufenta

Eligibility Criteria

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Inclusion Criteria

\- Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery

Exclusion Criteria

* non-english speaking patients
* patients who have allergy or intolerance to the study drugs or derivatives
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron Bern, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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ANES-2020-28605

Identifier Type: -

Identifier Source: org_study_id

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