Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
1 other identifier
interventional
53
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Oct 2020
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
October 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2021
CompletedResults Posted
Study results publicly available
June 28, 2022
CompletedJune 28, 2022
June 1, 2022
4 months
May 8, 2020
April 6, 2022
June 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival
Pain is assessed on a scale of 0-10 (whole numbers). A score of 0 being no pain, 10 being maximum imaginable pain. Data collected upon arrival to Post-Anesthesia Care Unit (PACU).
2 hours
Secondary Outcomes (2)
Opioid Use in Recovery Room
2 hours
OBAS Score
2 hours
Study Arms (2)
Sublingual Sufentanil
EXPERIMENTALParticipants in this arm will receive the intervention.
Control
NO INTERVENTIONParticipants in this arm will not receive an intervention.
Interventions
15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Eligibility Criteria
You may qualify if:
- \- Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery
You may not qualify if:
- non-english speaking patients
- patients who have allergy or intolerance to the study drugs or derivatives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aaron Berg
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Aaron Bern, MD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2020
First Posted
May 13, 2020
Study Start
October 14, 2020
Primary Completion
February 4, 2021
Study Completion
February 4, 2021
Last Updated
June 28, 2022
Results First Posted
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share