Opioids Following ACL
- 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
Group Intervention Description 25 opioid tablets perscribed oxycodone For 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 perscribed oxycodone For 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 perscribed oxycodone For 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
Name Time Method Post-operative pain 14 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
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie oxycodone's analgesic effects in postoperative pain management following ACL reconstruction?
How does the oxycodone protocol in NCT04278703 compare to standard-of-care opioid regimens for post-ACL surgery pain control?
Are there specific biomarkers that predict optimal patient response to postoperative opioid management protocols like NCT04278703?
What are the potential adverse events associated with oxycodone use in ACL reconstruction patients and how can they be mitigated?
What alternative analgesic combinations or non-opioid approaches are being explored for postoperative pain management in orthopedic surgeries like ACL reconstruction?
Trial Locations
- Locations (1)
Rothman Orthopaedics at Egg Harbor Township
🇺🇸Egg Harbor Township, New Jersey, United States
Rothman Orthopaedics at Egg Harbor Township🇺🇸Egg Harbor Township, New Jersey, United States