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Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

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ClinicalTrials.gov Identifier: NCT02959697
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Blepharoptosis Ptosis Drug: Subcut. + Subconj. Xylocaine Drug: Subcut. + Sham Subconj. Injection Procedure: Blepharoptosis Repair Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: 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.
Drug: Subcut. + Subconj. Xylocaine
Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
Other Name: Xylocaine

Procedure: Blepharoptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.
Other Name: Ptosis Repair

Sham Comparator: 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.
Drug: Subcut. + Sham Subconj. Injection
Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.
Other Name: Normal Saline

Procedure: Blepharoptosis Repair
Patients will undergo blepharoptosis repair using an anterior approach.
Other Name: Ptosis Repair




Primary Outcome Measures :
  1. 0-10 Numerical Pain Scale [ Time Frame: 2 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 :
  1. Presence of post-operative lagophthalmos/fluorescein staining [ Time Frame: 2 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.

  2. Post-Operative margin-reflex distance 1 [ Time Frame: 2 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959697


Contacts
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Contact: Matthew Lee-Wing, MD (204) 946-0649 matthew.lee-wing@myumanitoba.ca
Contact: Jeremy A Levi, MD (204) 510-0473 umlevi@myumanitoba.ca

Locations
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Canada, Manitoba
Buhler Eye Centre, Misericordia Hospital Recruiting
Winnipeg, Manitoba, Canada, R3C 1A2
Contact: Matthew Lee-Wing, MD    (204) 774-6581    matthew.lee-wing@myumanitoba.ca   
Private Office (Dr. Lee-Wing). 1010-233 Kennedy st. Recruiting
Winnipeg, Manitoba, Canada, R3C 3J5
Contact: Matthew Lee-Wing, MD    (204) 946-0649      
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Matthew Lee-Wing, MD University of Manitoba
  Study Documents (Full-Text)

Documents provided by University of Manitoba:

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02959697     History of Changes
Other Study ID Numbers: HS20066 (B2016:085)
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
Blepharoptosis
Ptosis
Surgery
Pain Reduction
Anesthetic
Local Anesthetic
Subconjunctival
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action