Clinical trial NCT02959697: Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Official title: Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharoptosis
Ptosis
Keywords: Blepharoptosis
Ptosis
Surgery
Pain Reduction
Anesthetic
Local Anesthetic
Subconjunctival
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 0-10 Numerical Pain Scale
timeFrame: 6 Years
Secondary outcomes:
measure: Presence of post-operative lagophthalmos/fluorescein staining
timeFrame: 6 Years
measure: Post-Operative margin-reflex distance 1
timeFrame: 6 Years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Buhler Eye Centre, Misericordia Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Matthew Lee-Wing, MD
role: PRINCIPAL_INVESTIGATOR
References: