Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Phase 4TerminatedNCT04561375

The Cleveland Clinic61 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Arthroscopy

Interventions

SufentanilDRUG

30 µg tablet of sublingual sufentanil

FentanylDRUG

50 µg fentanyl

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Total Consumption of Fentanyl

The total amount of fentanyl consumed in PACU.

Time frame: About 3 hours in PACU

Secondary Outcomes

Phase 1 Recovery Time

Recovery will be considered complete at the time an order is placed for progression to phase II.

Time frame: 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

Time frame: 1 - 2 hours.

Data from ClinicalTrials.gov

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