Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

NCT ID: NCT02959697

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2023-06-01

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.

Conditions

Blepharoptosis; Ptosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Subcut. + Subconj. Xylocaine

Intervention Type: DRUG

Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).

Blepharoptosis Repair

Intervention Type: PROCEDURE

Patients will undergo blepharoptosis repair using an anterior approach.

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.

Group Type: SHAM_COMPARATOR

Subcut. + Sham Subconj. Injection

Intervention Type: DRUG

Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.

Blepharoptosis Repair

Intervention Type: PROCEDURE

Patients will undergo blepharoptosis repair using an anterior approach.

Interventions

Subcut. + Subconj. Xylocaine

Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).

Intervention Type: DRUG

Subcut. + Sham Subconj. Injection

Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.

Intervention Type: DRUG

Blepharoptosis Repair

Patients will undergo blepharoptosis repair using an anterior approach.

Intervention Type: PROCEDURE

Other Intervention Names

Xylocaine; Normal Saline; Ptosis Repair

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Lee-Wing, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Buhler Eye Centre, Misericordia Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Matthew Lee-Wing, MD

Role: CONTACT

matthew.lee-wing@myumanitoba.ca

(204) 946-0649

Facility Contacts

Matthew Lee-Wing, MD

Role: primary

matthew.lee-wing@myumanitoba.ca

(204) 774-6581

Matthew Lee-Wing, MD

Role: primary

(204) 946-0649

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

HS20066 (B2016:085)

Identifier Type: -

Identifier Source: org_study_id