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RECRUITING
NCT06189781
PHASE4

Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-12-01

Completion Date

2027-06-30

Last Updated

2024-06-11

Healthy Volunteers

No

Interventions

DRUG

Ropivacaine injection

The local anesthetic group will be injected with ropivacaine 2mg/mL (3mg/kg), epinephrine 1mg/mL (0.5mg), and ketorolac 30mg/mL (0.5mg/kg). The maximum dose of ropivacaine regardless of patient weight will be 200mg. This is based on recommended maximum dose protocols from our anesthesia colleagues. If bilateral hips are involved, the total amount will be split evenly between the two sides.

DRUG

Bupivacaine, lidocaine, ropivacaine

The lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.

Locations (4)

Orthopaedic Institute for Children

Los Angeles, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA Medical Center, Santa Monica

Santa Monica, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States