Birth asphyxia and the neonatal brain: what do we know and when do we know it?
K B Nelson, E S Emery
https://pubmed.ncbi.nlm.nih.gov/8358954Actively Recruiting
Led by University of California, Los Angeles · Updated on 2024-06-11
90
Participants Needed
4
Research Sites
26 weeks
Total Duration
U
University of California, Los Angeles
Lead Sponsor
N
Northwestern University
Collaborating Sponsor
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
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
R
Rachel M Thompson, MD
N
Nicole J Hung, MD
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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K B Nelson, E S Emery
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