Peri-operative Use of a Pain Injection Versus Epidural in Pediatric Patients With Cerebral Palsy

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• under 18 years old

• diagnosis of cerebral palsy or similar neuromuscular disease

• undergoing uni- or bilateral proximal femoral osteotomy

Locations
United States
California
Orthopaedic Institute for Children
RECRUITING
Los Angeles
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
UCLA Medical Center, Santa Monica
RECRUITING
Santa Monica
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
NOT_YET_RECRUITING
Chicago
Contact Information
Primary
Rachel M Thompson, MD
rathompson@mednet.ucla.edu
213-742-1369
Backup
Nicole J Hung, MD
nhung@mednet.ucla.edu
310-592-5180
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 90
Treatments
Experimental: Pain Injection
The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac.
Active_comparator: Epidural
The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively.
Sponsors
Leads: University of California, Los Angeles
Collaborators: Northwestern University

This content was sourced from clinicaltrials.gov