Opioids Following ACL

NCT ID: NCT04278703

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2021-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Patients will be given a prescription for 15 opioid tablets for post-operative pain

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

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Patients will be given a prescription for 25 opioid tablets for post-operative pain

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

Group Type ACTIVE_COMPARATOR

oxycodone

Intervention Type DRUG

Patients will be given a prescription for 35 opioid tablets for post-operative pain

Interventions

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Oxycodone

Patients will be given a prescription for 15 opioid tablets for post-operative pain

Intervention Type DRUG

Oxycodone

Patients will be given a prescription for 25 opioid tablets for post-operative pain

Intervention Type DRUG

oxycodone

Patients will be given a prescription for 35 opioid tablets for post-operative pain

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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2020 TJ 03

Identifier Type: -

Identifier Source: org_study_id

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