Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Conditions
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Pain, Pain, Acute, Anesthesia

Intervention / Treatment
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* Drug: Sublingual Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Sufentanil<br>Participants in this arm will receive the intervention. | Drug: Sublingual Sufentanil<br>* 15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.<br>* Other names: Sufenta;|
| No Intervention: Control<br>Participants in this arm will not receive an intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 hours | 
| 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. | 2 hours |