Back to resultsIntraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Primary Purpose
Pain, Pain, Acute, Anesthesia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sublingual Sufentanil
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sublingual Sufentanil
Control
Arm Description
Participants in this arm will receive the intervention.
Participants in this arm will not receive an intervention.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Opioid Use in Recovery Room
Opioid medication type and dose will be recorded and converted to milligram morphine equivalents. Outcome is reported as the total milligram morphine equivalents of opioid medication used in the recovery room.
OBAS Score
Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04387136
Brief Title
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Official Title
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Acute, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Sufentanil
Arm Type
Experimental
Arm Description
Participants in this arm will receive the intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not receive an intervention.
Intervention Type
Drug
Intervention Name(s)
Sublingual Sufentanil
Other Intervention Name(s)
Dsuvia, Sufenta
Intervention Description
15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Primary Outcome Measure Information:
Title
Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Opioid Use in Recovery Room
Description
Opioid medication type and dose will be recorded and converted to milligram morphine equivalents. Outcome is reported as the total milligram morphine equivalents of opioid medication used in the recovery room.
Time Frame
2 hours
Title
OBAS Score
Description
Overall Benefit of Analgesic Score (OBAS) is a 7-item multi-dimensional survey that assesses analgesia benefits. Items are scored on a scale from 0 (minimal) to 4 (maximal). Total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Bern, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
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