Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery

Knee Arthroscopy Clinical Trial

Official title:

A Pilot Study Assessing the Effects of Sublingual Sufentanil 30 µg on Postoperative Recovery From Ambulatory Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04561375
• Other study ID #: 20-642
• Status: Terminated
• Phase: Phase 4
• Start date: December 11, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Arthroscopy

Intervention

Drug:
• Sufentanil
30 µg tablet of sublingual sufentanil
• Fentanyl
50 µg fentanyl

Locations

Country	Name	City	State
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Consumption of Fentanyl in PACU	The total amount of fentanyl consumed in PACU.	About 3 hours in PACU
Primary	Total Consumption of Fentanyl	The total amount of fentanyl consumed in PACU.	About 3 hours in PACU
Secondary	Phase 1 Recovery Time	Recovery will be considered complete at the time an order is placed for progression to phase II.	1.5 hours
Secondary	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	1 - 2 hours.