Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

NCT ID: NCT01350024

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-01

Study Completion Date

2016-07-30

Brief Summary

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Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.

The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.

Detailed Description

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Conditions

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Blepharoptosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Frontal Nerve Block

Patients will receive a frontal nerve block for anesthesia

Group Type ACTIVE_COMPARATOR

Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine

Intervention Type PROCEDURE

Frontal Nerve Block 5 cc will be administered preoperatively once.

Subconjucntival Injection

Patients will receive a subconjunctival injection for anesthesia

Group Type ACTIVE_COMPARATOR

Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine

Intervention Type PROCEDURE

Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above

Interventions

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Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine

Frontal Nerve Block 5 cc will be administered preoperatively once.

Intervention Type PROCEDURE

Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine

Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Patient with ptosis that requires correction
* Patient is able to consent for themselves

Exclusion Criteria

* Patient unable to complete survey
* Patient had prior lid surgery
* Patient taking chronic pain medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wendy Lee

Assoc. Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bascom Palmer Eye Institute

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20100631

Identifier Type: -

Identifier Source: org_study_id

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