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Procedure
Pain Injection vs Epidural Anesthesia for Hip Surgery in Children with Cerebral Palsy
Phase 4
Recruiting
Led By Rachel M Thompson, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients under 18 years old
Patients undergoing uni- or bilateral proximal femoral osteotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 48 hours after surgery
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial is studying different methods of managing pain in children with cerebral palsy after hip surgery. Currently, opioids are commonly used but they have negative side effects. Epidural anesthesia is effective but has risks
Who is the study for?
This trial is for pediatric patients with cerebral palsy who are undergoing hip surgery. It's aimed at those who may have difficulty communicating their pain due to developmental delays or intellectual disabilities. Patients must be suitable candidates for either epidural anesthesia or surgical site injections.
What is being tested?
The study compares two pain management methods post-hip surgery: multimodal surgical site injections (using drugs like Ropivacaine) versus traditional epidural anesthesia. The goal is to see which method better controls pain without the side effects associated with opioids.
What are the potential side effects?
Epidural anesthesia might cause issues like infection, technical difficulties during insertion, and potential damage to existing medical devices inside the body. Injections could lead to localized reactions but generally have a lower risk profile compared to epidurals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am under 18 years old.
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I am having surgery to correct the bone in my upper leg.
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I have been diagnosed with cerebral palsy or a similar condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first 48 hours after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 48 hours after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight
Secondary study objectives
Hospital length of stay measured in days
Parent satisfaction measured on a scale of 1-5
Postoperative pain scores measured by Visual Analogue Scale/Faces Pain Scale/Face, Legs, Activity, Cry, Consolability Scale
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pain InjectionExperimental Treatment1 Intervention
The local anesthetic group will be injected with a combination of ropivacaine, epinephrine, and ketorolac.
Group II: EpiduralActive Control1 Intervention
The control group will receive epidural anesthesia. Lumbar epidural anesthesia will be started intra-operatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine injection
2012
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,205 Total Patients Enrolled
20 Trials studying Infections
85,655 Patients Enrolled for Infections
Northwestern UniversityOTHER
1,652 Previous Clinical Trials
961,425 Total Patients Enrolled
6 Trials studying Infections
2,633 Patients Enrolled for Infections
Rachel M Thompson, MDPrincipal InvestigatorUniversity of California, Los Angeles
3 Previous Clinical Trials
124 Total Patients Enrolled