Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy

Recruiting now · Phase 4

Conditions studied: Cerebral Palsy, Hip Dysplasia, Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT06189781

Run by

University of California, Los Angeles

People needed

90

Starts

2023-12-01

Expected to finish

2027-06-30

Last updated by the study team

2024-06-11

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• under 18 years old
• diagnosis of cerebral palsy or similar neuromuscular disease
• undergoing uni- or bilateral proximal femoral osteotomy

You may not qualify if…

• ongoing preoperative opioid use
• history of allergic reaction to any component of the pain injection
• history of adverse reaction to epidural anesthesia

Where it is running

• Orthopaedic Institute for Children — Los Angeles, California, United States (enrolling)
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States (enrolling)
• UCLA Medical Center, Santa Monica — Santa Monica, California, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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