Summary

Eligibility
for people ages up to 18 years (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Rachel M Thompson, MD

Description

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.

Official Title

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

Details

Over the past decade, there has been an ongoing shift away from the use of opioids in the postoperative setting due to both their negative side effects and their high potential for dependence and abuse. Various new techniques for multimodal pain management are increasingly being utilized in adult orthopaedics, including injection of local anesthetics and analgesic agents. These techniques aim to block pain directly at the site of injection in order to reduce postoperative pain while minimizing systemic effects and preserving motor function, allowing for early mobilization. Numerous randomized controlled trials in both the arthroplasty and adult trauma populations have demonstrated reduced pain and narcotic consumption with local analgesia injection, but there is scant evidence on the efficacy of similar injections in pediatric surgical patients. While robust evidence demonstrating both safety and efficacy of these injections has led to routine use in the adult orthopaedic population, use in pediatric patients still remains limited, likely due to a lack of level I therapeutic evidence.

Local anesthetic injections offer several theoretical advantages over current pain management modalities. When compared with other methods of anesthesia, including epidural anesthesia or some peripheral nerve blocks, local anesthetic injections preserve motor function, allowing for early mobilization and rehabilitation. Additionally, they do not require specialized equipment or anesthesia personnel and can be administered in the operating room without significantly affecting the duration of the procedure. While a mainstay in traditional pain management protocols, epidural anesthesia in the pediatric CP population poses specific risks including damage to preexisting intrathecal baclofen pumps and iatrogenic infection. Moreover, epidural insertion can be a technically demanding procedure in these patients given high rates of concomitant neuromuscular scoliosis. Prior retrospective studies comparing peripheral nerve and lumbar plexus blocks compared to epidural anesthesia have shown mixed results in decreasing pain scores and opioid use in this patient population. As described in Preliminary Data section below, the investigators' pilot randomized control trial demonstrated significantly decreased pain scores and narcotic use postoperatively in pediatric patients with CP who received multimodal analgesia injection compared to placebo while undergoing hip surgery. The present study aims to substantively contribute to current literature by providing level I evidence comparing the safety and efficacy of surgical site injections with epidural anesthesia in a patient population for whom pain management remains challenging.

Keywords

Cerebral Palsy, Hip Dysplasia, Pain, Postoperative, Hip Dislocation, Developmental Dysplasia of the Hip, Congenital Hip Dislocation, Postoperative Pain, Lidocaine, Bupivacaine, Ropivacaine, Ropivacaine injection, Bupivacaine, lidocaine, ropivacaine, Pain Injection, Epidural

Eligibility

You can join if…

Open to people ages up to 18 years

  • under 18 years old
  • diagnosis of cerebral palsy or similar neuromuscular disease
  • undergoing uni- or bilateral proximal femoral osteotomy

You CAN'T join if...

  • ongoing preoperative opioid use
  • history of allergic reaction to any component of the pain injection
  • history of adverse reaction to epidural anesthesia

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Medical Center, Santa Monica accepting new patients
    Santa Monica California 90404 United States
  • Orthopaedic Institute for Children accepting new patients
    Los Angeles California 90007 United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago not yet accepting patients
    Chicago Illinois 60611 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06189781
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated