Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment

June 29, 2023 updated by: Montefiore Medical Center

Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment Who Are Undergoing Ambulatory Surgery- a Case Series

In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age range 18-100 years
  • Currently taking Suboxone
  • ASA (American Society of Anesthesiology) physical score 1-3
  • Able to provide a signed informed consent
  • General anesthesia (either endotracheal intubation or laryngeal mask airway) or MAC (monitored anesthesia care) without the use of regional anesthesia

Exclusion Criteria:

  • Known allergic reactions to Dsuvia and its excipients
  • Severe respiratory illness including exacerbation of asthma attack
  • Significant intraoperative hemodynamic instability
  • Use of Regional anesthesia techniques

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV.
Drug: Dsuvia
Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
No Intervention: Control
Subjects will be receive routine standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Equivalence
Time Frame: During day of surgery
Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU).
During day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit)
Time Frame: During stay in PACU, up until discharge from PACU
How much time did subject take to become considered 'fit to discharge?'
During stay in PACU, up until discharge from PACU
Need for Additional Opioids Following Surgery
Time Frame: PACU stay to 24 hours post hospital discharge
A measure of how any additional opioids subjects were administered
PACU stay to 24 hours post hospital discharge
Time to Take the First Additional Opioid
Time Frame: 24 hours post hospital discharge
Average time for administration of first additional opioid.
24 hours post hospital discharge
Adverse Events in the PACU
Time Frame: During PACU stay, up until discharge from PACU
Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU
During PACU stay, up until discharge from PACU
Adverse Events Post Discharge From PACU
Time Frame: 24 hours
Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Naum Shaparin, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Actual)

November 17, 2022

Study Completion (Actual)

November 18, 2022

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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