Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
Key facts
- Who runs it
- University of California, Los Angeles
- Where
- Chicago, Los Angeles, and Santa Monica, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 90 people, planned
- Started
- 1 Dec 2023
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ropivacaine injection
- Bupivacaine, lidocaine, ropivacaine
- Record updated
- 11 June 2024
Who can take part
- Age
- Up to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- under 18 years old
- diagnosis of cerebral palsy or similar neuromuscular disease
- undergoing uni- or bilateral proximal femoral osteotomy
Who cannot take part
- history of allergic reaction to any component of the pain injection
- history of adverse reaction to epidural anesthesia
- ongoing preoperative opioid use
Where in United States
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United StatesContact: Elizabeth KleinNot yet recruiting
- Orthopaedic Institute for ChildrenLos Angeles, United StatesContact: Nicole J Hung, MDTaking people
- Ronald Reagan UCLA Medical CenterLos Angeles, United StatesContact: Nicole J Hung, MDTaking people
- UCLA Medical Center, Santa MonicaSanta Monica, United StatesContact: Nicole J Hung, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Pain InjectionTreatment being tested
The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac.
Treatment: Ropivacaine injection
- EpiduralExisting treatment, for comparison
The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively.
Treatment: Bupivacaine, lidocaine, ropivacaine
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy
- Record updated
- 11 June 2024