Clinical trial NCT06274008: Exparel vs. ACB With Bupivacaine for ACL Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: ACL Tear
Opioid Misuse
Pain
Anxiety
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Approximately 13% of high school seniors have reported nonmedical use of prescription opioids in their lifetimes with 8.7% to 11% reporting use within the last year. The second most common source of opioids (36.9%) in this population is leftover medication from previous legitimate prescriptions after injury or procedures. Before injury or surgery, most children and adolescents are narcotic naive. Medical use of opioids in this population increases the risk for nonmedical opioid misuse after high school by 33% (1). As orthopaedic surgeons, the surgeons are in a powerful position to understand and affect change in the adolescent population through patient/parent education and through controlling the amount and type of pain medications prescribed. The investigators propose a Double Blinded RCT of adolescents with ACL +/- meniscus tear to either bupivacaine ACB or Bupivacaine Liposome Injectable Suspension ACB (Exparel) to test whether injectable suspension reduces at home narcotic consumption postoperatively. Currently there is limited data available for the pediatric population and no known randomized controlled trials. Bupivacaine Liposome Injectable Suspension is FDA approved for use in adults but has been used in this pediatric population off-label for many years. Exparel is now FDA approved and indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia. While widely used in the settings of a regional block in adolescents undergoing ACL reconstruction and other surgeries, it does not have specific FDA approval for the use in blocks. This is not uncommon practice and in fact many of the drugs used in pediatrics do not have specific approval by the FDA(2).

After enrollment, the research subject will be randomized into one of two arms and the anesthesiologist will be notified of the arm. Data will be collected at baseline, on day of surgery, and on days 1 through 14 postoperatively. Participants will be instructed to wear Actigraphs in the days leading up to surgery to obtain baseline sleep activity data.

Eligibility 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.

Primary outcomes:
measure: At-home narcotic consumption by the patients as measured by the medication form completed by parents post discharge
timeFrame: Postoperative days 1-3, 7, and 14.
Secondary outcomes:
measure: Postoperative pain level of child
timeFrame: Postoperative days 1-3, 7, and 14.
measure: Functional disability of child
timeFrame: Baseline, Postoperative days 1-3, 7, and 14.
measure: Parent and child anxiety
timeFrame: Baseline, Postoperative days 1-3, 7, and 14.
measure: Child pain
timeFrame: Postoperative days 1-3, 7, and 14.
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC Children's Hospital
state: California
Study officials:
References:
citation: McCabe SE, West BT, Boyd CJ. Leftover prescription opioids and nonmedical use among high school seniors: a multi-cohort national study. J Adolesc Health. 2013 Apr;52(4):480-5. doi: 10.1016/j.jadohealth.2012.08.007. Epub 2012 Nov 22.