Exparel vs. ACB With Bupivacaine for ACL Reconstruction
Status unconfirmed · Phase 1
Conditions studied: ACL Tear, Opioid Misuse, Pain, Anxiety
In brief
Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear.
Key facts
- Study ID
- NCT06274008
- Run by
- Children's Hospital of Orange County
- People needed
- 96
- Starts
- 2023-10-12
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-02-23
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients who are 7-17 years old undergoing elective ACL reconstruction/repair with American Society of Anesthesiologists (ASA) Classification 1-2 at Children's Hospital of Orange County (CHOC).
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Surgery scheduled between the hours of 8am - 4pm
You may not qualify if…
- No prior major surgery (e.g. transplant procedures, cardiac, cranial surgeries)
- Learning disability or developmental delay. Learning disability or developmental delay will have been assessed by an outside specialist. Diagnosis will have either been communicated to attending physician by the patient or will be located in patient's medical record. Anything that would impede survey completion.
Where it is running
- CHOC Children's Hospital — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
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