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NCT01394523 · ClinicalTrials.gov registry record · Phase 2
Caudal Versus Rectus Sheath Study
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01394523: Clinical Trial Phase 2 study, sponsored by Nationwide Children's Hospital.
NCT01394523 is a Phase 2 study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01394523, a Phase 2 study, was terminated before completion, sponsored by Nationwide Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia
Primary Outcome
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
Interventions
- DRUG Bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Why NCT01394523 stopped before completion
NCT01394523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which Bupivacaine is the first listed.
NCT01394523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01394523 about?
NCT01394523 is a clinical study titled "Caudal Versus Rectus Sheath Study". The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques i...
What is the current status of trial NCT01394523?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2011-08. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01394523?
The interventions under investigation include: Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT01394523?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01394523's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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