Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
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 |
---|---|---|
|
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
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:
|
No Intervention: Control Participants in this arm will not receive an intervention. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
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.- ANES-2020-28605
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
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
|
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
|
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
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 |
bergx831@umn.edu |
- ANES-2020-28605