Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioids Following ACL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278703
Recruitment Status : Enrolling by invitation
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Oxycodone Drug: oxycodone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Utilization of Opioid Medication Following ACL Reconstruction
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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

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 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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278703


Locations
Layout table for location information
United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04278703    
Other Study ID Numbers: 2020 TJ 03
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents