MedPath

Opioids Following ACL

Not Applicable
Conditions
Pain, Postoperative
Interventions
Registration Number
NCT04278703
Lead Sponsor
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Not specified
Target Recruitment
192
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
25 opioid tablets perscribedoxycodoneFor this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
15 opioid tablets perscribedoxycodoneFor this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
35 opioid tablets perscribedoxycodoneFor this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain
Primary Outcome Measures
NameTimeMethod
Post-operative pain14 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Rothman Orthopaedics at Egg Harbor Township

🇺🇸

Egg Harbor Township, New Jersey, United States

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