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Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

Primary Purpose

Blepharoptosis, Ptosis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Subcut. + Subconj. Xylocaine
Subcut. + Sham Subconj. Injection
Blepharoptosis Repair
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis focused on measuring Blepharoptosis, Ptosis, Surgery, Pain Reduction, Anesthetic, Local Anesthetic, Subconjunctival

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buhler Eye Centre, Misericordia HospitalRecruiting
  • Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Subcut. + Subconj. Injection

Subcut. + Sham Subconj. Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 31, 2016
Last Updated
June 7, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02959697
Brief Title
Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Official Title
Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis, Ptosis
Keywords
Blepharoptosis, Ptosis, Surgery, Pain Reduction, Anesthetic, Local Anesthetic, Subconjunctival

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subcut. + Subconj. Injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Subcut. + Sham Subconj. Injection
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Subcut. + Subconj. Xylocaine
Other Intervention Name(s)
Xylocaine
Intervention Description
Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
Intervention Type
Drug
Intervention Name(s)
Subcut. + Sham Subconj. Injection
Other Intervention Name(s)
Normal Saline
Intervention Description
Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.
Intervention Type
Procedure
Intervention Name(s)
Blepharoptosis Repair
Other Intervention Name(s)
Ptosis Repair
Intervention Description
Patients will undergo blepharoptosis repair using an anterior approach.
Primary Outcome Measure Information:
Title
0-10 Numerical Pain Scale
Description
Patients will be asked to describe the intraoperative pain they experienced in each eye during surgery. Results will be compared with McNemar's test.
Time Frame
6 Years
Secondary Outcome Measure Information:
Title
Presence of post-operative lagophthalmos/fluorescein staining
Description
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.
Time Frame
6 Years
Title
Post-Operative margin-reflex distance 1
Description
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.
Time Frame
6 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Lee-Wing, MD
Phone
(204) 946-0649
Email
matthew.lee-wing@myumanitoba.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Lee-Wing, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buhler Eye Centre, Misericordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Lee-Wing, MD
Phone
(204) 774-6581
Email
matthew.lee-wing@myumanitoba.ca
Facility Name
Private Office (Dr. Lee-Wing). 1010-233 Kennedy st.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 3J5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Lee-Wing, MD
Phone
(204) 946-0649

12. IPD Sharing Statement

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Subconjunctival Injection of Local Anesthetic in Anterior Blepharoptosis Repair

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