Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Pain Clinical Trial

Official title:

Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387136
• Other study ID #: ANES-2020-28605
• Status: Completed
• Phase: Phase 4
• Start date: October 14, 2020
• Est. completion date: February 4, 2021

Study information

• Verified date: June 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 4, 2021
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Pain
• Pain, Acute

Intervention

Drug:
• Sublingual Sufentanil
15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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