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NCT06189781 · ClinicalTrials.gov registry record · Phase 4
Pain Injection Versus Epidural Anesthesia for Hip Surgery in Pediatric Patients With Cerebral Palsy
A Phase 4 study of Pain, Postoperative and Cerebral Palsy, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 4
- Study locations
NCT06189781 is a Phase 4 study of Pain, Postoperative and Cerebral Palsy that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 90 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT06189781, a Phase 4 study of Pain, Postoperative and Cerebral Palsy, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 4
- Study locations
Study Summary
Pain management in pediatric patients presents a difficult challenge. Unlike adults, pediatric patients often cannot communicate their pain management needs clearly. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability and verbal limitations. Current literature indicates pain as a common experience for children with CP but has been understudied in this population. Moreover, inadequate post-operative pain control can result in negative physiologic and psychological complications and lead to poor surgical outcomes. Currently, perioperative pain management following orthopaedic procedures in pediatric patients follows traditional protocols that rely on the administration of opioid medications despite their known adverse side effects including nausea, vomiting, itching, constipation, urinary retention, confusion, and respiratory depression. Epidural anesthesia is a key modality in traditional pain management for pediatric patients with CP given its proven efficacy in decreasing pain and managing spasticity. Yet, administering epidural anesthesia in this patient population poses several risks including damage to preexisting intrathecal baclofen pumps, iatrogenic infection, and technically demanding insertion given high rates of concomitant neuromuscular scoliosis. Alternatively, multimodal analgesic injections theoretically offer an efficacious adjunct to traditional pain management protocols with a lower risk profile. Preliminary data from our study group's pilot randomized control trial comparing the safety and efficacy of a multimodal surgical site injection to placebo showed decreased pain scores and narcotic consumption postoperatively in this patient population. Based on these promising results, the objective of this randomized control trial is to evaluate the efficacy of a multimodal surgical site injection compared to epidural anesthesia for postoperative pain control following oper
Conditions Studied
Interventions
- DRUG Ropivacaine injection
- DRUG Bupivacaine, lidocaine, ropivacaine
Study Locations (4)
California
- Orthopaedic Institute for Children - Los Angeles
- Ronald Reagan UCLA Medical Center - Los Angeles
- UCLA Medical Center, Santa Monica - Santa Monica
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06189781
The ClinicalTrials.gov registry entry for NCT06189781 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (67% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Ropivacaine injection is the first listed.
NCT06189781 reports 4 study locations spanning 2 distinct geographic areas - top geographies include California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06189781 about?
NCT06189781 is a clinical study titled "Pain Injection Versus Epidural Anesthesia for Hip Surgery 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. This is especially true in patients with cerebral palsy (CP), who often have concomitant developmental delay, intellectual disability ...
What is the current status of trial NCT06189781?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2023-12-01. Estimated completion is 2027-06-30.
What conditions does trial NCT06189781 study?
This clinical trial studies the following conditions: Pain, Postoperative, Cerebral Palsy, Hip Dysplasia.
What interventions are being tested in trial NCT06189781?
The interventions under investigation include: Ropivacaine injection (DRUG), Bupivacaine, lidocaine, ropivacaine (DRUG).
Who is sponsoring clinical trial NCT06189781?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06189781 being conducted?
This trial has 4 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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