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

May 24, 2017 updated by: Dr. Wendy Lee, University of Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Frontal Nerve Block
Patients will receive a frontal nerve block for anesthesia
Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Frontal Nerve Block 5 cc will be administered preoperatively once.
ACTIVE_COMPARATOR: Subconjucntival Injection
Patients will receive a subconjunctival injection for anesthesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control
Time Frame: 24 hour after surgery
Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
24 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of ptosis surgery
Time Frame: 2 months
Standard measures include marginal reflex distanced, palpebral fissure and levator fucntion will be used to assess the efficacy of the ptosis surgery and compared to the type of anesthesia the patient was given.
2 months
Pain Control
Time Frame: 1 hour after surgery
completion of survey to assess pain after surgery has been completed.
1 hour after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2011

Primary Completion (ACTUAL)

July 30, 2016

Study Completion (ACTUAL)

July 30, 2016

Study Registration Dates

First Submitted

May 5, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (ESTIMATE)

May 9, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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