Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

Blepharoptosis Clinical Trial

Official title:

Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02959697
• Other study ID #: HS20066 (B2016:085)
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: University of Manitoba
• Contact: Matthew Lee-Wing, MD
• Phone: (204) 946-0649
• Email: matthew.lee-wing[@]myumanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Ptosis

Intervention

Drug:
• Subcut. + Subconj. Xylocaine
Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
• Subcut. + Sham Subconj. Injection
Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.

Procedure:
• Blepharoptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.

Locations

Country	Name	City	State
Canada	Buhler Eye Centre, Misericordia Hospital	Winnipeg	Manitoba
Canada	Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-10 Numerical Pain Scale	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	Presence of post-operative lagophthalmos/fluorescein staining	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
Secondary	Post-Operative margin-reflex distance 1	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