Using Exparel to control pain after MPFL reconstruction in kids
Prospective Evaluation of Post-operative Pain Management Using Exparel in the Pediatric Population
This study sees if adding Exparel to standard local anesthesia reduces post-op pain and opioid pill use in patients aged 13 and older having an isolated MPFL reconstruction.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | All |
| Sponsor | Texas Scottish Rite Hospital for Children Academic / other |
| Locations | 1 site (Frisco, Texas) |
| Trial ID | NCT06559215 on ClinicalTrials.gov |
What this trial studies
This single-institution, single-blinded randomized controlled trial will enroll 100 pediatric patients (minimum 80 completers) undergoing isolated MPFL reconstruction and randomize them to receive Exparel plus Marcaine versus Marcaine-only local infiltration. Patients and families will provide assent/consent and patient-reported pain outcomes will be collected using VAS scores and an institution pain questionnaire on postoperative days 1, 4, and 7. Narcotic consumption (number of pills taken) and a pain management satisfaction survey at day 7 are secondary outcomes, with demographic and surgical data pulled from the electronic medical record. The trial is conducted at Texas Scottish Rite Hospital for Children (Frisco, TX) and is single-blinded to the patient.
Who should consider this trial
Good fit: Ideal candidates are patients aged 13 years or older scheduled for an isolated MPFL reconstruction who can provide assent and whose guardian can give consent.
Not a fit: Patients younger than 13, those requiring additional procedures (fracture repair, arthrotomy, tibial tubercle osteotomy, or other non-isolated lower-extremity surgery), pregnant patients, those with BMI ≥ 40, or anyone with prior hypersensitivity to Exparel/local anesthetics are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower short-term pain and reduce opioid pill use after MPFL reconstruction in adolescents.
How similar studies have performed: Adult studies of liposomal bupivacaine (Exparel) have shown modest reductions in pain and opioid use for some procedures, but pediatric evidence is limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be aged 13+ years at time of surgery * Must present with injury requiring an isolated MPFL Reconstruction * Ability to provide assent, legally appointed representative available to provide informed consent Exclusion Criteria: * Patient \<13 years old * Requires fracture repair or another non-standardized surgery * Any MPFL Reconstruction that requires the use of arthrotomy or a tibial tubercle osteotomy * Any lower extremity procedure that is not an isolated MPFL Reconstruction * Patient pregnancy * Inability to provide assent or legally appointed representative to provide informed consent * Prior history of hypersensitivity to Exparel or any local anesthesia * BMI ≥ 40
Where this trial is running
Frisco, Texas
- Texas Scottish Rite Hospital for Children — Frisco, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Philip Wilson, MD — Texas Scottish Rite Hospital for Children
- Study coordinator: Robert Van Pelt, MPH
- Email: bobby.vanpelt@tsrh.org
- Phone: 2145597456
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.