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NCT01812044 · ClinicalTrials.gov registry record · NA
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
A NA study of Strabismus, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT01812044: Completed NA study of Strabismus, sponsored by Duke University.
NCT01812044 is a NA study of Strabismus that has completed, run by Duke University. The registered enrollment target is 57 participants, below the 725-participant average among 9 other Strabismus trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812044, a NA study of Strabismus, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.
Primary Outcome
Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is r
Conditions Studied
Interventions
- DRUG subtenons anesthetic - preservative-free bupivacaine 0.75%
- DRUG topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
- DRUG topical control - 0.5 cc of Hypromellose 0.3% gel
- DRUG subtenons control - 0.5 cc of Normal Saline
Study Locations (1)
North Carolina
- Duke Eye Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2013-03 |
| Phase | NA |
What the finished NCT01812044 record still lists
NCT01812044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 725-participant average among 9 other Strabismus trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Strabismus appearing as the primary indexed condition, and to 4 interventions - of which subtenons anesthetic - preservative-free bupivacaine 0.75% is the first listed.
NCT01812044 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01812044 about?
NCT01812044 is a clinical study titled "Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery". The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surge...
What is the current status of trial NCT01812044?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2013-03.
What conditions does trial NCT01812044 study?
This clinical trial studies the following conditions: Strabismus.
What interventions are being tested in trial NCT01812044?
The interventions under investigation include: subtenons anesthetic - preservative-free bupivacaine 0.75% (DRUG), topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel (DRUG), topical control - 0.5 cc of Hypromellose 0.3% gel (DRUG), subtenons control - 0.5 cc of Normal Saline (DRUG).
Who is sponsoring clinical trial NCT01812044?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01812044 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Strabismus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01812044's enrollment target sits among peer trials
57 8th of 9 higher than 2 of 9 other Strabismus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Strabismus 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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Amblyopia (Lazy Eye) Treatment Study
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Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
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