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NCT04074265 · ClinicalTrials.gov registry record · Phase 4
Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy
A Phase 4 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT04074265 is a Phase 4 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 34 participants.
The verdict
NCT04074265, a Phase 4 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. Adequate pain control after surgery is pivotal for these patients in order to prevent negative physiologic and psychologic complications and to improve surgical outcomes. There is an ongoing shift away from the use of opioids in the post-operative setting due to both their negative side effects and their high potential for dependence and abuse. A variety of new techniques of multimodal pain management have been developed and utilized in elective orthopaedic procedures. Injection of local anesthetics is becoming a widely popular technique utilized in adult arthroplasty. This technique blocks pain directly at the site of injection, and therefore can improve post-operative pain while minimizing side effects. Evidence has demonstrated this technique to be both safe and effective, resulting in reduced opioid consumption post-operatively. However, this technique has not been studied for use in pediatric patients, a population in which reduced narcotic use is equally, if not more important than in adult patients. This study is a prospective, randomized controlled trial with 2 parallel arms. The goal of this study is to assess the efficacy of a surgical-site pain injection administered in pediatric patients with cerebral palsy undergoing major hip surgery. Patients who are scheduled to undergo surgery will be randomized to either intervention (injection of a pain cocktail) or placebo (injection of normal saline). The pain cocktail includes three medications: ropivacaine (a local anesthetic), ketorolac (an anti-inflammatory medication), and epinephrine (a medication to constrict blood vessels and increase the duration of action of any co-administered medications). A surgeon who is blinded to treatment group will administer the injection at the end of the procedure, prior to the patient waking from anesthesia.
Interventions
- DRUG Ropivacaine injection
- DRUG normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2023-04-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04074265
The ClinicalTrials.gov registry entry for NCT04074265 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ropivacaine injection is the first listed.
NCT04074265 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04074265 about?
NCT04074265 is a clinical study titled "Peri-operative Use of a Pain Injection in Pediatric Patients With Cerebral Palsy". Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. Adequate pain control after surgery is pivotal for these patients in order to prevent negative physiologic and psychologic complicatio...
What is the current status of trial NCT04074265?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2019-12-01. Estimated completion is 2023-04-30.
What interventions are being tested in trial NCT04074265?
The interventions under investigation include: Ropivacaine injection (DRUG), normal saline (DRUG).
Who is sponsoring clinical trial NCT04074265?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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