Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

June 7, 2022 updated by: University of Manitoba
Blepharoptosis (ptosis) repair is a common and generally well tolerated surgical procedure usually performed using local anesthetic. However, a subset of patients appears to experience intraoperative pain/discomfort during ptosis repair using an anterior approach with subcutaneous local anesthetic. Posterior subconjuctival local anesthetic is currently used for eyelid procedures such as chalazion incision and drainage and full-thickness eyelid resections. The purpose of this study is to determine whether an additional subconjunctival injection of local anesthetic, through the posterior aspect of the eyelid, reduces intraoperative pain during anterior ptosis repair.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited from Dr. Matthew Lee-Wing's practice. Eligible participants include those requiring bilateral blepharoptosis repair requiring an anterior surgical approach. The patient will need to have a similar degree of ptosis in each eye (as measured by each eye's "Marginal Reflex Distance #1"). Patients will be given information regarding the outcomes of interest, and informed re: risks and benefits of participating.

Upon agreeing to participate, the patient will be asked to sign a consent form indicating their wish to participate in the study (see below).

Each patient will have blepharoptosis repair surgery on both of their eyes. One eye will act as a control in that the operation will proceed in a manner in-line with current practice (IE with subcutaneous local anesthetic alone). The other eye will receive both subcutaneous local anesthetic, as well as an additional injection of local anesthetic underneath the conjunctiva of the upper eyelid (IE on the inner surface of the eyelid). The eye/side receiving only the standard, subcutaneous local anesthetic will also receive a sham injection of normal saline in order to prevent the patient from knowing which side is receiving the additional anesthetic dose. Dr. Lee-Wing will perform all of the surgeries within the study, and will be blinded as to which patient is receiving the additional anesthetic. The blinding will be accomplished by the assisting treatment room nurse, who will use an algorithm to randomly select which eyelid will receive the subconjunctival Xylocaine and which will receive the subconjunctival Normal Saline.

Following their procedure, each patient will complete a questionnaire designed to assess their intraoperative pain.

Statistical analysis will be performed, and will compare the patient's intraoperative pain rating for the eyelid that received the sham Normal Saline injection and the eyelid that received the Xylocaine injection. The presence of post-operative lagophthalmos/fluorescein staining will be compared between the two groups, as will the post-operative Marginal Reflex Distance 1. The above comparisons will be made using McNemar's test.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1A2
      • Winnipeg, Manitoba, Canada, R3C 3J5
        • Recruiting
        • Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.
        • Contact:
          • Matthew Lee-Wing, MD
          • Phone Number: (204) 946-0649

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be 18 years of age or older and able to give informed consent in English
  • Must have bilateral blepharoptosis undergoing repair using an anterior approach
  • The degree of ptosis must be approximately symmetrical, with a difference in margin-reflex distance of 1 mm or less between the two sides

Exclusion Criteria:

  • Previous eyelid surgery or trauma
  • Congenital, mechanical, myogenic or neurogenic forms of ptosis
  • Unable to give informed consent

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcut. + Subconj. Injection
Patients will undergo standard blepharoptosis repair using an anterior approach, with an added injection of local anesthetic (Xylocaine) beneath the conjunctiva of the lid being operated on. They will still receive the standard subcutaneous local anesthetic given during blepharoptosis repair.
Drug: Subcut. + Subconj. Xylocaine
Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
Other Names:
  • Xylocaine
Procedure: Blepharoptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.
Other Names:
  • Ptosis Repair
Sham Comparator: Subcut. + Sham Subconj. Injection
Patients will undergo standard blepharoptosis repair using an anterior approach, however they will not receive the additional subconjunctival Xylocaine injection. Instead, they will receive a sham injection of Normal Saline to prevent them from knowing which eye received the additional anesthetic.
Procedure: Blepharoptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.
Other Names:
  • Ptosis Repair
Drug: Subcut. + Sham Subconj. Injection
Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
0-10 Numerical Pain Scale
Time Frame: 6 Years
Patients will be asked to describe the intraoperative pain they experienced in each eye during surgery. Results will be compared with McNemar's test.
6 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of post-operative lagophthalmos/fluorescein staining
Time Frame: 6 Years
The presence or absence of lagophthalmos and fluorescein staining will be assessed in each eye at the post-operative follow up appointment, and will be compared with McNemar's test.
6 Years
Post-Operative margin-reflex distance 1
Time Frame: 6 Years
Post-operative margin-reflex distance 1 (MDR1 - distance between the pupillary light reflex and the lower edge of the upper lid) will be measured in each eye. The difference between the MDR1 of each eye will be analyzed using paired Student's T-testing.
6 Years

Collaborators and Investigators

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

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Matthew Lee-Wing, MD, University of Manitoba

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)

September 1, 2017

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 6, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS20066 (B2016:085)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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