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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of California, Los Angeles

About this trial

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

Qualifiers

under 18 years old

diagnosis of cerebral palsy or similar neuromuscular disease

undergoing uni- or bilateral proximal femoral osteotomy

Disqualifiers

ongoing preoperative opioid use

history of allergic reaction to any component of the pain injection

history of adverse reaction to epidural anesthesia

Trial design

Treatments tested in this trial

  • Ropivacaine injection
  • Bupivacaine, lidocaine, ropivacaine

Treatment groups

90 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

Northwestern University

Collaborator