Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

Study Overview
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Brief Summary
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In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.

Official Title
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Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Dsuvia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range 18-100 years Currently taking Suboxone ASA (American Society of Anesthesiology) physical score 1-3 Able to provide a signed informed consent General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia Exclusion Criteria: Known allergic reactions to Dsuvia and its excipients Severe respiratory illness including exacerbation of asthma attack Significant intraoperative hemodynamic instability Use of Regional anesthesia techniques

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV. | Drug: Dsuvia<br>* Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)<br>|
| No Intervention: Control<br>Subjects will be receive routine standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Equivalence | Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU). | During day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit) | How much time did subject take to become considered 'fit to discharge?' | During stay in PACU, up until discharge from PACU | 
| Need for Additional Opioids Following Surgery | A measure of how any additional opioids subjects were administered | PACU stay to 24 hours post hospital discharge | 
| Time to Take the First Additional Opioid | Average time for administration of first additional opioid. | 24 hours post hospital discharge | 
| Adverse Events in the PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU | During PACU stay, up until discharge from PACU | 
| Adverse Events Post Discharge From PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU | 24 hours |