Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2020

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Sublingual Sufentanil
    • Participants in this arm will receive the intervention.
  • No Intervention: Control
    • Participants in this arm will not receive an intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Initial Numeric Rating Scale (NRS) Pain Score upon Arrival
    • Time Frame: 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 Measures

  • Length of time in Post-Anesthesia Care Unit (PACU)
    • Time Frame: 2 hours
    • Outcome reported as the mean length of time (in minutes) patients spend in Post-Anesthesia Care Unit (PACU) by arm.
  • Opioid Use in Recovery Room
    • Time Frame: 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.
  • Postoperative Nausea and Vomiting (PONV)
    • Time Frame: 2 hours
    • Number of participants in each arm who are treated for nausea and/or vomiting.
  • Final Numeric Rating Scale (NRS) Pain Score upon Discharge
    • Time Frame: 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 discharge from Post-Anesthesia Care Unit (PACU).
  • Change in Pain from Admission to Discharge
    • Time Frame: 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 and discharge from Post-Anesthesia Care Unit (PACU). Outcome is reported as the mean difference between both scores by arm.
  • OBAS Score
    • Time Frame: 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.
  • Anesthesia Wake-up Time
    • Time Frame: 30 minutes
    • Anesthesia wake-up time is measured as the duration (in minutes) from procedure closure to removal of endotracheal tube or laryngeal mask airway.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Minnesota
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Aaron Bern, MD, Principal Investigator, University of Minnesota
  • Overall Contact(s)
    • Aaron Berg, MD, 612-624-9990, bergx831@umn.edu

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