Phase 4
N=98
Are Opioids Needed After ACL Reconstruction
Anterior Cruciate Ligament Rupture
Bottom Line
View on ClinicalTrials.gov: NCT04285853 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Pain Level: Numeric Rating Scale — 4.6; 4.5; 4.7; 5.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxycodone (Drug); Placebo oral tablet (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Level: Numeric Rating Scale |
4.6; 4.5; 4.7; 5.1; 3.8; 3.8 | — |
Summary
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
Eligibility Criteria
Inclusion Criteria
- Males and females
- Aged 14-40 years
- Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.
Exclusion Criteria
- Revision and/or contralateral ACL reconstruction procedures
- Allergies to local anesthetics
- Chronic pain medication use
- Weight <50 kg, local infections
- Known coagulopathies,
- Liver dysfunction or renal failure
Data sourced from ClinicalTrials.gov (NCT04285853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.