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Procedure

Pain Injection for 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

Study 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.Check my eligibility

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.See study design

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and first 48 hours after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average postoperative narcotic consumption measured in morphine equivalents per kilograms of patient body weight

Secondary outcome measures

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

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,532 Previous Clinical Trials

10,265,178 Total Patients Enrolled

2 Trials studying Cerebral Palsy

64 Patients Enrolled for Cerebral Palsy

Northwestern UniversityOTHER

1,589 Previous Clinical Trials

916,997 Total Patients Enrolled

4 Trials studying Cerebral Palsy

439 Patients Enrolled for Cerebral Palsy

Rachel M Thompson, MDPrincipal InvestigatorUniversity of California, Los Angeles

3 Previous Clinical Trials

124 Total Patients Enrolled

1 Trials studying Cerebral Palsy

34 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current patient population enrolled in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this particular clinical trial is currently in the process of actively recruiting eligible candidates. The initial posting date for this trial was recorded as December 1st, 2023 and it received its most recent update on December 30th, 2023. To complete the study successfully, a total of 90 participants will be enrolled from four distinct sites."

Answered by AI

Are there ongoing efforts to actively enroll participants for this medical study?

"Indeed, as stated on clinicaltrials.gov, this trial is actively seeking participants. The initial posting of the trial took place on December 1st, 2023, and it was last edited on December 30th, 2023."

Answered by AI

Recent research and studies

Journal of Bone and Joint SurgeryJournal

Efficacy of Surgical-site, Multimodal Drug Injection Following Operative Management of Femoral Fractures

Koehler, Daniel, J. Lawrence Marsh, Matthew Karam, Catherine Fruehling, and Michael Willey. 2017. “Efficacy of Surgical-site, Multimodal Drug Injection Following Operative Management of Femoral Fractures”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.16.00733.

clinicaltrials.govStudy

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

Rachel Thompson, MD 2023. "Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189781.

All > Cerebral Palsy