Opioid Analgesic Reduction Study (OARS) - Pilot

Post Operative Pain Clinical Trial

— OARS-Pilot  

Official title:

Opioid Analgesic Reduction Study (OARS) - Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283499
• Other study ID #: Pro2020001891
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: June 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

Description:

A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 26, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.

• Subjects who are English speaking and are able to provide consent will be considered.

• Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

Exclusion Criteria:

Subjects who self-report the following history will be excluded from participating:

• Individual under the age of 18

• History of gastrointestinal bleeding and/or peptic ulcer

• History of renal disease (excluding kidney stones)

• History of hepatic disease

• History of bleeding disorder

• History of respiratory depression

• Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively

• Active or untreated asthma

• History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia

• Currently taking any of the following medications:

• CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression

• CNS depressants.

• Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism

• History of drug or alcohol abuse (excludes marijuana use)

• Family history of drug or alcohol abuse in a first degree relative

• Has had one or more opioid prescription filled within the past 6 months

• Currently pregnant or lactating

Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

• Prior participation in this study

• Inability or refusal to provide informed consent

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• OPIOID
Analgesic assignment
• NON-OPIOID
Analgesic assignment

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	University of Illinois Chicago	Chicago	Illinois
United States	Rutgers University	Newark	New Jersey
United States	University of Rochester	Rochester	New York

Sponsors (5)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)	1st day
Primary	Pain Level	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain	Average for the 1st and 2nd day
Primary	Pain Level	Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain	Average for the first seven days post surgery
Secondary	Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	1st night
Secondary	Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the 1st and 2nd night
Secondary	Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the 1st, 2nd and 3rd night
Secondary	Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the first seven nights post surgery
Secondary	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always); The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?; Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	1st day
Secondary	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always); The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?; Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the 1st and 2nd day
Secondary	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always); The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?; Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the 1st, 2nd and 3rd day
Secondary	Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always); The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?; Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the first seven days post surgery
Secondary	Overall Satisfaction	Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)	Average for the first seven days post surgery