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Opioids Following ACL

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Oxycodone
oxycodone
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Rothman Orthopaedics at Egg Harbor Township

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

15 opioid tablets perscribed

25 opioid tablets perscribed

35 opioid tablets perscribed

Arm Description

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Outcomes

Primary Outcome Measures

Post-operative pain
Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
February 18, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04278703
Brief Title
Opioids Following ACL
Official Title
The Utilization of Opioid Medication Following ACL Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
15 opioid tablets perscribed
Arm Type
Active Comparator
Arm Description
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Arm Title
25 opioid tablets perscribed
Arm Type
Active Comparator
Arm Description
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Arm Title
35 opioid tablets perscribed
Arm Type
Active Comparator
Arm Description
For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Patients will be given a prescription for 15 opioid tablets for post-operative pain
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Patients will be given a prescription for 25 opioid tablets for post-operative pain
Intervention Type
Drug
Intervention Name(s)
oxycodone
Intervention Description
Patients will be given a prescription for 35 opioid tablets for post-operative pain
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable
Time Frame
14 days post-operative

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rothman Orthopaedics at Egg Harbor Township
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Opioids Following ACL

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