Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

Not Applicable

• Conditions: Blepharoptosis; Ptosis
• Interventions: Drug: Subcut. + Sham Subconj. Injection; Drug: Subcut. + Subconj. Xylocaine; Procedure: Blepharoptosis Repair

• Registration Number: NCT02959697
• Lead Sponsor: University of Manitoba

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-06
• Study First Posted: 2016-11-09
• Study Start: 2017-09-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-10
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcut. + Sham Subconj. Injection	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.
Subcut. + Sham Subconj. Injection	Blepharoptosis Repair	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.
Subcut. + Subconj. Injection	Blepharoptosis Repair	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.
Subcut. + Subconj. Injection	Subcut. + Subconj. Xylocaine	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.

Primary Outcome Measures

Name	Time	Method
0-10 Numerical Pain Scale	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.

Secondary Outcome Measures

Name	Time	Method
Post-Operative margin-reflex distance 1	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.
Presence of post-operative lagophthalmos/fluorescein staining	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.

Trial Locations

Locations (2)

Buhler Eye Centre, Misericordia Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.; 🇨🇦 Winnipeg, Manitoba, Canada