Actively Recruiting
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
Led by University of California, Los Angeles · Updated on 2024-06-11
90
Participants Needed
4
Research Sites
186 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 18 years old
- Diagnosis of cerebral palsy or similar neuromuscular disease
- Undergoing uni- or bilateral proximal femoral osteotomy
You will not qualify if you...
- Ongoing preoperative opioid use
- History of allergic reaction to any component of the pain injection
- History of adverse reaction to epidural anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Orthopaedic Institute for Children
Los Angeles, California, United States, 90007
Actively Recruiting
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
UCLA Medical Center, Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
Research Team
R
Rachel M Thompson, MD
CONTACT
N
Nicole J Hung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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