Opioids Following ACL

February 18, 2020 updated by: Rothman Institute Orthopaedics

The Utilization of Opioid Medication Following ACL Reconstruction

The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Not Applicable

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
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Orthopaedics at Egg Harbor Township

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

Exclusion Criteria:

  • Concomitant procedure other than meniscectomy or meniscal repair.
  • ACL revision
  • History of chronic pre-operative opioid use
  • History of substance abuse
  • Workmen's compensation claims
  • Pregnancy

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 15 opioid tablets perscribed
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Drug: Oxycodone
Patients will be given a prescription for 15 opioid tablets for post-operative pain
Drug: Oxycodone
Patients will be given a prescription for 25 opioid tablets for post-operative pain
ACTIVE_COMPARATOR: 25 opioid tablets perscribed
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Drug: Oxycodone
Patients will be given a prescription for 15 opioid tablets for post-operative pain
Drug: Oxycodone
Patients will be given a prescription for 25 opioid tablets for post-operative pain
ACTIVE_COMPARATOR: 35 opioid tablets perscribed
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Drug: oxycodone
Patients will be given a prescription for 35 opioid tablets for post-operative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 14 days post-operative
Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable
14 days post-operative

Collaborators and Investigators

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

Sponsor

Rothman Institute Orthopaedics

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)

February 15, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020 TJ 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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