Knee Arthroscopy
Conditions
Brief summary
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.
Detailed description
A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery. The results will help us estimate treatment effect and determine sample size for a subsequent full-scale clinical trial. Primary Endpoint: total amount of fentanyl consumed during hospital admission. Secondary Endpoints: 1) phase I recovery time; and, 2) time to fitness for discharge. Exploratory Endpoints: 1) intraoperative hemodynamics; 2) intraoperative opioid use; 3) intraoperative sevoflurane use; 4) postoperative pain; 5) postoperative sedation and cognitive recovery 6) time to first request for analgesia; and, 7) incidence of nausea and vomiting between the end of anesthesia and hospital discharge.
Interventions
DRUGSufentanil
30 µg tablet of sublingual sufentanil
DRUGFentanyl
50 µg fentanyl
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older; * Scheduled for elective knee arthroscopy without anticipated ligamentous repair; * Planned general anesthesia without a regional block or wound infiltration with local anesthesia; * Planned day-of-surgery discharge.
Exclusion criteria
* Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery; * Known hypersensitivity to sufentanil or components of DSUVIA; * Patients with an allergy or hypersensitivity to opioids; * Pregnancy or actively breastfeeding; * Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug; * Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Consumption of Fentanyl | About 3 hours in PACU | The total amount of fentanyl consumed in PACU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 Recovery Time | 1.5 hours | Recovery will be considered complete at the time an order is placed for progression to phase II. |
| Time to Fitness for PACU Discharge | 1 - 2 hours. | This will be determined per facility protocol-scheduled assessments using the CCF Phase II Discharge Scoring tool. The time that the minimum acceptable score of 14 is achieved will be recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Consumption of Fentanyl in PACU | About 3 hours in PACU | The total amount of fentanyl consumed in PACU. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group 30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia.
Sufentanil: 30 µg tablet of sublingual sufentanil | 35 |
| Control Group placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia
Fentanyl: 50 µg fentanyl | 26 |
| Total | 61 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 7.4 | 51.5 years STANDARD_DEVIATION 12.3 | 53.8 years STANDARD_DEVIATION 7.8 |
| Body Mass Index (BMI) | 29.9 kg/m2 STANDARD_DEVIATION 5.2 | 33.8 kg/m2 STANDARD_DEVIATION 7.4 | 31.6 kg/m2 STANDARD_DEVIATION 5.9 |
| Race/Ethnicity, Customized non-White | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 25 Participants | 60 Participants |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 20 Participants | 16 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 26 |
| other Total, other adverse events | 0 / 35 | 0 / 26 |
| serious Total, serious adverse events | 0 / 35 | 0 / 26 |
Outcome results
Primary
Total Consumption of Fentanyl
The total amount of fentanyl consumed in PACU.
Time frame: About 3 hours in PACU
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Total Consumption of Fentanyl | 150 µg | 0 Participants |
| Intervention Group | Total Consumption of Fentanyl | 25 µg | 4 Participants |
| Intervention Group | Total Consumption of Fentanyl | 100 µg | 4 Participants |
| Intervention Group | Total Consumption of Fentanyl | 50 µg | 2 Participants |
| Intervention Group | Total Consumption of Fentanyl | 0 µg | 25 Participants |
| Control Group | Total Consumption of Fentanyl | 150 µg | 1 Participants |
| Control Group | Total Consumption of Fentanyl | 50 µg | 5 Participants |
| Control Group | Total Consumption of Fentanyl | 0 µg | 11 Participants |
| Control Group | Total Consumption of Fentanyl | 25 µg | 5 Participants |
| Control Group | Total Consumption of Fentanyl | 100 µg | 4 Participants |
p-value: 0.06795% CI: [0.13, 1.07]proportional odds logistic regression
Secondary
Phase 1 Recovery Time
Recovery will be considered complete at the time an order is placed for progression to phase II.
Time frame: 1.5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Phase 1 Recovery Time | 77 minutes | Standard Deviation 30 |
| Control Group | Phase 1 Recovery Time | 66 minutes | Standard Deviation 18 |
p-value: 0.14797.5% CI: [-5.8, 26]Regression, Linear
Secondary
Time to Fitness for PACU Discharge
This will be determined per facility protocol-scheduled assessments using the CCF Phase II Discharge Scoring tool. The time that the minimum acceptable score of 14 is achieved will be recorded
Time frame: 1 - 2 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Time to Fitness for PACU Discharge | 120 minutes | Standard Deviation 47 |
| Control Group | Time to Fitness for PACU Discharge | 114 minutes | Standard Deviation 31 |
p-value: 0.46397.5% CI: [-18, 34]Regression, Linear
Other Pre-specified
Total Consumption of Fentanyl in PACU
The total amount of fentanyl consumed in PACU.
Time frame: About 3 hours in PACU
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Total Consumption of Fentanyl in PACU | 0 µg |
| Control Group | Total Consumption of Fentanyl in PACU | 25 µg |
p-value: 0.03295% CI: [-25, 0]Wilcoxon (Mann-Whitney)