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Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

NCT01812044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-04-26

Study results available
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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.

Conditions

  • Strabismus

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

Sponsors & Collaborators

Principal Investigators

  • Laura Enyedi, MD · Duke Eye Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01812044 on ClinicalTrials.gov