Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

NeuroTherapia, Inc.

Status and phase

Terminated

Phase 4

Conditions

Knee Arthroscopy

Treatments

Drug: Sufentanil

Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT04561375

20-642

Details and patient eligibility

About

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

Full 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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.