Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
RecruitingPhase 4NCT06189781
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 opera…
Study details
- Official title
- Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Hip Dysplasia
- Pain, Postoperative
- Interventions
- Drug: Ropivacaine injection
- Drug: Bupivacaine, lidocaine, ropivacaine
- Sponsor
- University of California, Los Angeles
- Collaborators
- Northwestern University
- Start date
- 2023-12-01
- Primary completion
- 2026-12-30
- Sex
- All
- Age range
- to 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06189781