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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06189781
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Hip Dysplasia
  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 1, 2023
Status verified
Jun 2024
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight [ Time Frame: First 48 hours after surgery ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Orthopaedic Institute for ChildrenLos AngelesCalifornia90007
Nicole J Hung, MD
310-592-5180
Rachel M Thompson, MD (PRINCIPAL_INVESTIGATOR)
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095
Nicole J Hung, MD
[email protected]
310-592-5180
Rachel M Thompson, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical Center, Santa MonicaSanta MonicaCalifornia90404
Nicole J Hung, MD
310-592-5180
Rachel M Thompson, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Elizabeth Klein
[email protected]
Vineeta T Swaroop, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Orthopaedic Institute for Children· Los Angeles, CARonald Reagan UCLA Medical Center· Los Angeles, CAUCLA Medical Center, Santa Monica· Santa Monica, CAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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