NCT02959697

Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Subcut. + Subconj. Xylocaine	Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
DRUG	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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2016-11-09
• Last updated: 2022-06-10

Locations

2 sites across 1 country: Canada