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NCT04278703 Clinical Trial

Opioids Following ACL

Pain, Postoperative Clinical Trial

Official title:
The Utilization of Opioid Medication Following ACL Reconstruction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04278703
Other study ID # 2020 TJ 03
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date March 2021

Study information
Verified date February 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 192
Est. completion date March 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone
Patients will be given a prescription for 15 opioid tablets for post-operative pain
• Oxycodone
Patients will be given a prescription for 25 opioid tablets for post-operative pain
• oxycodone
Patients will be given a prescription for 35 opioid tablets for post-operative pain

Locations
Country Name City State
United States Rothman Orthopaedics at Egg Harbor Township Egg Harbor Township New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 14 days post-operative
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