Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Study Overview
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Brief Summary
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A pilot study to evaluate the effect of incorporating sublingual sufentanil into our perioperative opioid regimen for ambulatory orthopedic surgery.

Detailed Description
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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.

Official Title
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A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery

Conditions
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Knee Arthroscopy

Intervention / Treatment
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* Drug: Sufentanil
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>30 µg tablet of sublingual sufentanil preoperatively and fentanyl placebo at induction of anesthesia. | Drug: Sufentanil<br>* 30 µg tablet of sublingual sufentanil<br>|
| Placebo Comparator: Control Group<br>placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia | Drug: Fentanyl<br>* 50 µg fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Consumption of Fentanyl | The total amount of fentanyl consumed in PACU. | About 3 hours in PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 Recovery Time | Recovery will be considered complete at the time an order is placed for progression to phase II. | 1.5 hours | 
| 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 | 1 - 2 hours. |