Opioids Following ACL

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Drug: oxycodone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT04278703

2020 TJ 03

Details and patient eligibility

About

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).

Enrollment: 192 estimated patients

Sex

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 3 patient groups

15 opioid tablets perscribed

Active Comparator group

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

Treatment:

Drug: Oxycodone

Drug: Oxycodone

25 opioid tablets perscribed

Active Comparator group

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

Treatment:

Drug: Oxycodone

Drug: Oxycodone

35 opioid tablets perscribed

Active Comparator group

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

Treatment:

Drug: oxycodone