Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Stopped early · Phase 4

Conditions studied: Knee Arthroscopy

In brief

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

Key facts

Study ID

NCT04561375

Run by

The Cleveland Clinic

People needed

61

Starts

2020-12-11

Expected to finish

2022-07-01

Last updated by the study team

2023-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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