Pain, Pain, Acute, Anesthesia
Conditions
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.
Interventions
15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sublingual Sufentanil 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. | 26 |
| Control Participants in this arm will not receive an intervention. | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Deviation by SOC staff | 1 | 2 |
Baseline characteristics
| Characteristic | Sublingual Sufentanil | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 14 Participants | 18 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 4 / 25 | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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).
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival | 4 score on a scale |
| Control | Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival | 4 score on a scale |
Secondary
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.
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | OBAS Score | 1.0 score |
| Control | OBAS Score | 3.0 score |
Secondary
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.
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sublingual Sufentanil | Opioid Use in Recovery Room | 7.5 mg (morphine equivalent) |
| Control | Opioid Use in Recovery Room | 15.0 mg (morphine equivalent) |