Actively Recruiting

Phase 4
Age: 0 - 18Years
All Genders
ID06189781

Peri-operative Use of a Pain Injection Versus Epidural Anesthesia in Pediatric Patients With Cerebral Palsy

Led by University of California, Los Angeles · Updated on 2024-06-11

90

Participants Needed

4

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

N

Northwestern University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Pain management is particularly challenging for pediatric patients with cerebral palsy (CP) due to communication difficulties and associated developmental and intellectual disabilities. This research evaluates and compares the effectiveness of a multimodal surgical site injection versus epidural anesthesia in controlling postoperative pain after hip surgery in children with CP. The study aims to improve pain control while reducing the risks associated with opioid use and epidural anesthesia in this vulnerable population. Participants will be assigned to receive either an injection of local anesthetics and analgesics including ropivacaine, epinephrine, and ketorolac, or lumbar epidural anesthesia using agents such as bupivacaine, lidocaine, and ropivacaine. The local anesthetic injection is given during surgery and aims to reduce pain at the surgical site while preserving motor function. The epidural anesthesia is administered intra-operatively and monitored by the anesthesia team. This randomized trial provides a direct comparison of these two pain management approaches following hip surgery. Throughout the study, researchers will measure postoperative narcotic use during the first 48 hours after surgery as the primary outcome. Secondary outcomes include pain scores over 2 to 4 days, hospital length of stay, and parent satisfaction assessed 2 to 3 weeks after surgery. Participants will be closely monitored for safety, with data collected on pain, medication use, and recovery progress. The total study duration includes the immediate postoperative period and follow-up assessments several weeks later.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Under 18 years old
  • Diagnosis of cerebral palsy or similar neuromuscular disease
  • Scheduled for uni- or bilateral proximal femoral osteotomy surgery
Not Eligible

You will not qualify if you...

  • Current use of opioid medications before surgery
  • History of allergic reaction to any component of the pain injection
  • History of adverse reaction to epidural anesthesia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day and immediate postoperative period

Participants receive either a local anesthetic injection or epidural anesthesia during hip surgery to manage pain.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 2 to 3 weeks post-surgery

Participants are monitored for pain levels, narcotic use, hospital stay length, and parent satisfaction following surgery.

Approximately 3 follow-up visits

Trial Site Locations

Total: 4 locations

1

Orthopaedic Institute for Children

Los Angeles, California, United States, 90007

Actively Recruiting

2

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

3

UCLA Medical Center, Santa Monica

Santa Monica, California, United States, 90404

Actively Recruiting

4

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

Chicago, Illinois, United States, 60611

Not Yet Recruiting

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Research Team

R

Rachel M Thompson, MD

N

Nicole J Hung, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Pain Assessment and Treatment in Children With Significant Impairment of the Central Nervous System.

Julie Hauer, Amy J Houtrow, SECTION ON HOSPICE AND PALLIATIVE MEDICINE, COUNCIL ON CHILDREN WITH DISABILITIES

https://pubmed.ncbi.nlm.nih.gov/28562301

The Perioperative Anesthetic Management of the Pediatric Patient with Special Needs: An Overview of Literature.

Alessandra Ciccozzi, Barbara Pizzi, Alessandro Vittori...

https://pubmed.ncbi.nlm.nih.gov/36291372