Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT04387136
Collaborator
(none)
53
1
2
3.7
14.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sublingual Sufentanil
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Actual Study Start Date :
Oct 14, 2020
Actual Primary Completion Date :
Feb 4, 2021
Actual Study Completion Date :
Feb 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sublingual Sufentanil

Participants in this arm will receive the intervention.

Drug: 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.
Other Names:
  • Dsuvia
  • Sufenta
  • No Intervention: Control

    Participants in this arm will not receive an intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival [2 hours]

      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

    1. Opioid Use in Recovery Room [2 hours]

      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.

    2. OBAS Score [2 hours]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Aaron Bern, MD, University of Minnesota

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT04387136
    Other Study ID Numbers:
    • ANES-2020-28605
    First Posted:
    May 13, 2020
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Sublingual Sufentanil Control
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention.
    Period Title: Overall Study
    STARTED 26 27
    COMPLETED 25 25
    NOT COMPLETED 1 2

    Baseline Characteristics

    Arm/Group Title Sublingual Sufentanil Control Total
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention. Total of all reporting groups
    Overall Participants 26 27 53
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    24
    92.3%
    26
    96.3%
    50
    94.3%
    >=65 years
    2
    7.7%
    1
    3.7%
    3
    5.7%
    Sex: Female, Male (Count of Participants)
    Female
    12
    46.2%
    9
    33.3%
    21
    39.6%
    Male
    14
    53.8%
    18
    66.7%
    32
    60.4%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Sublingual Sufentanil Control
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention.
    Measure Participants 25 25
    Median (Inter-Quartile Range) [score on a scale]
    4
    4
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Sublingual Sufentanil Control
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention.
    Measure Participants 25 25
    Median (Inter-Quartile Range) [mg (morphine equivalent)]
    7.5
    15.0
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Sublingual Sufentanil Control
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention.
    Measure Participants 25 25
    Median (Inter-Quartile Range) [score]
    1.0
    3.0

    Adverse Events

    Time Frame 16 weeks from baseline
    Adverse Event Reporting Description
    Arm/Group Title Sublingual Sufentanil Control
    Arm/Group Description Participants in this arm will receive the intervention. 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. Participants in this arm will not receive an intervention.
    All Cause Mortality
    Sublingual Sufentanil Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/25 (0%)
    Serious Adverse Events
    Sublingual Sufentanil Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/25 (0%)
    Other (Not Including Serious) Adverse Events
    Sublingual Sufentanil Control
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/25 (16%) 1/25 (4%)
    Gastrointestinal disorders
    Emesis 1/25 (4%) 1 0/25 (0%) 0
    Post-operative nausea and vomiting 1/25 (4%) 1 0/25 (0%) 0
    Psychiatric disorders
    Anxiety 2/25 (8%) 3 1/25 (4%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Aaron Berg
    Organization University of Minnesota
    Phone 612-625-7675
    Email bergx831@umn.edu
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT04387136
    Other Study ID Numbers:
    • ANES-2020-28605
    First Posted:
    May 13, 2020
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022