drugset / Trial / NCT06189781

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

NCT06189781

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-12-01
Primary completion
2026-12-30
Completion
2027-06-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified Other
Subject Epinephrine Other / unclassified 0.5 mg Other
Subject Epinephrine Other / unclassified 1 mg/ml Other
Subject Ketorolac Other / unclassified 0.5 mg/kg Other
Subject Ketorolac Other / unclassified 30 mg/ml Other
Comparator Lidocaine Other / unclassified Other
Subject Ropivacaine Other / unclassified 2 mg/ml Other
Subject Ropivacaine Other / unclassified 3 mg/kg Other