NCT06189781 Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
| NCT ID | NCT06189781 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, Los Angeles |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression. Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following operative management of hip dysplasia in pediatric patients with CP.
Eligibility Criteria
Inclusion Criteria: * under 18 years old * diagnosis of cerebral palsy or similar neuromuscular disease * undergoing uni- or bilateral proximal femoral osteotomy Exclusion Criteria: * ongoing preoperative opioid use * history of allergic reaction to any component of the pain injection * history of adverse reaction to epidural anesthesia
Contact & Investigator
Rachel M Thompson, MD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT06189781 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06189781 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06189781 currently recruiting?
Yes, NCT06189781 is actively recruiting participants. Contact the research team at rathompson@mednet.ucla.edu for enrollment information.
Where is the NCT06189781 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Santa Monica, United States, Chicago, United States.
Who is sponsoring the NCT06189781 clinical trial?
NCT06189781 is sponsored by University of California, Los Angeles. The principal investigator is Rachel M Thompson, MD at University of California, Los Angeles. The trial plans to enroll 90 participants.
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