Efficacy of Buprenorphine on Postoperative Endodontic Analgesia (EBPEA)

April 19, 2019 updated by: Thomas A. Montagnese, University Hospitals Cleveland Medical Center
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland 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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered

Exclusion Criteria:

  • pregnancy, allergy to buprenorphine, allergy to local anesthetic

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: buprenorphine and local anesthetic
buprenorphine added to local anesthetic
Drug: Buprenorphine
Buprenorphine plus local anesthetic
Drug: lidocaine, epinephrine (Local anesthetic)
2% lidocaine 1:100,000 epinephrine
PLACEBO_COMPARATOR: sterile saline and local anesthetic
sterile saline (placebo) added to local anesthetic
Drug: lidocaine, epinephrine (Local anesthetic)
2% lidocaine 1:100,000 epinephrine
Drug: Sterile saline
Placebo 1,8 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
Time Frame: two years
The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.
two years

Collaborators and Investigators

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

Sponsor

University Hospitals Cleveland Medical Center

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)

April 1, 2017

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

July 1, 2018

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (ACTUAL)

August 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHClevelandMCBupStudy

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

No

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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