Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Phase 4

Completed

• Conditions: Anesthesia; Pain; Pain, Acute
• Interventions: Drug: Sublingual Sufentanil

• Registration Number: NCT04387136
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Study Start: 2020-10-14
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Results First Submitted: 2022-04-06
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-21
• Last Update Submitted: 2022-06-21
• Results First Posted: 2022-06-28
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery

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Exclusion Criteria

• non-english speaking patients
• patients who have allergy or intolerance to the study drugs or derivatives

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Sufentanil	Sublingual Sufentanil	Participants in this arm will receive the intervention.

Primary Outcome Measures

Name	Time	Method
Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival	2 hours	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).

Secondary Outcome Measures

Name	Time	Method
OBAS Score	2 hours	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.
Opioid Use in Recovery Room	2 hours	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States