Actively Recruiting

Phase 4
Age: 0 - 18Years
All Genders
NCT06189781

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Under 18 years old
  • Diagnosis of cerebral palsy or similar neuromuscular disease
  • Undergoing uni- or bilateral proximal femoral osteotomy
Not Eligible

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

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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

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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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