Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of California, Los Angeles
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
under 18 years old
diagnosis of cerebral palsy or similar neuromuscular disease
undergoing uni- or bilateral proximal femoral osteotomy
Disqualifiers
ongoing preoperative opioid use
history of allergic reaction to any component of the pain injection
history of adverse reaction to epidural anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine injection
DrugThe 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
DrugThe lumbar epidural group will receive a combination of either/or bupivacaine, lidocaine, and ropivacaine, which will be monitored by the anesthesia team.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Pain InjectionExperimental treatment 1 intervention
Group B: EpiduralActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight
This describes one outcome measure where the amount of opiates consumed will be expressed in morphine equivalents divided by the body weight of patients measured in kilograms.
Time frame
First 48 hours after surgerySecondary outcomes
1
Postoperative pain scores measured by Visual Analogue Scale/Faces Pain Scale/Face, Legs, Activity, Cry, Consolability Scale
Pain score assessments will be completed in the post-anesthesia care unit, and every 4 hours following the surgical procedure. Scores will be collected by nursing staff on the inpatient ward and recorded in the electronic medical record. The type of pain score collection will vary based on patient age and level of intellectual disability. In verbal children, either the Visual Analogue Scale or Faces Pain Scale will be employed. In non-verbal children, the Face, Legs, Activity, Cry, Consolability Scale will be employed. A higher score indicates greater pain intensity. Both scales are from 0 (minimum) -10 (maximum), where 0 indicates no pain and 10 indicate maximal pain.
Time frame
2-4 days2
Hospital length of stay measured in days
Postoperative hospital length of stay
Time frame
2-4 days3
Parent satisfaction measured on a scale of 1-5
Parent satisfaction will be based on a standardized, validated questionnaire taken by parents in person at the first post-operative clinic visit aimed to assess their satisfaction with their child's pain management peri-operatively. Each question is answered with a score of either 1-5, with 1 being the best outcome and 5 being the worst outcome. The score for each question will be summed together to come up with a total score. A higher total score indicates a worse level of satisfaction with perioperative pain management.
Time frame
2-3 weeks postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Northwestern University
Collaborator
Source ClinicalTrials.gov