Comparing Exparel and Bupivacaine for Pain Management in ACL Surgery
Prospective Randomized Trial (RCT) of Adductor Canal Block With Bupivacaine Liposome Injectable Suspension (Exparel) for Anterior Cruciate Ligament Reconstruction vs. Standard Adductor Canal Block (ACB) With Bupivacaine
PHASE1 · Children's Hospital of Orange County · NCT06274008
This study is trying to see if a new pain medication called Exparel can help young athletes have less pain and use fewer narcotics after ACL surgery compared to the standard treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Orange County (other) |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06274008 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of extended-release Bupivacaine Liposome Injectable Suspension (Exparel) compared to standard Bupivacaine Adductor Canal Block in reducing postoperative narcotic consumption in adolescents undergoing anterior cruciate ligament (ACL) reconstruction. The study will involve a double-blinded randomized controlled trial design, enrolling patients aged 7-17 years who are scheduled for elective ACL surgery. The goal is to address the rising concern of opioid misuse among young athletes by potentially minimizing their exposure to narcotics post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 7-17 years undergoing elective ACL reconstruction with ASA Classification 1-2.
Not a fit: Patients with prior major surgeries or those with learning disabilities or developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce opioid consumption in adolescents after ACL surgery, thereby lowering the risk of opioid misuse.
How similar studies have performed: While there is limited data available for the pediatric population, the use of Bupivacaine Liposome Injectable Suspension has been FDA approved for adults, indicating potential for success in similar applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Orange, California
- CHOC Children's Hospital — Orange, California, United States (RECRUITING)
Study contacts
- Study coordinator: Haydee Cortes
- Email: haydee.cortes@choc.org
- Phone: 714-456-2837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ACL Tear, Opioid Misuse, Pain, Anxiety