Recruiting

Subconjunctival Anesthetic

Sponsor:

University of Manitoba

Code:

NCT02959697

Conditions

Blepharoptosis

Ptosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Subcut. + Subconj. Xylocaine

Subcut. + Sham Subconj. Injection

Blepharoptosis Repair

Study Details

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.

Conditions

Blepharoptosis

Ptosis

Study ID

NCT02959697

Start date

Sep 1, 2017

Status verified date

May, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

May 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Subcut. + Subconj. Xylocaine

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

Subcut. + Sham Subconj. Injection

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

Blepharoptosis Repair

Patients will undergo blepharoptosis repair using an anterior approach.

Primary outcome measure

  • 0-10 Numerical Pain Scale [ Time Frame: 6 Years ]

Central Contacts and Locations

Central contacts

Matthew Lee-Wing, MD

(204) 946-0649matthew.lee-wing@myumanitoba.ca

Locations

Buhler Eye Centre, Misericordia Hospital

Recruiting

Winnipeg, Manitoba, Canada, R3C 1A2

Contacts

Matthew Lee-Wing, MD

(204) 774-6581matthew.lee-wing@myumanitoba.ca

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

Recruiting

Winnipeg, Manitoba, Canada, R3C 3J5

Contacts

Matthew Lee-Wing, MD

(204) 946-0649

More Information

Sponsor

University of Manitoba

Last update posted

Jun 10, 2022

Last verified

May, 2022

Keywords

  • Blepharoptosis
  • Ptosis
  • Surgery
  • Pain Reduction
  • Anesthetic
  • Local Anesthetic
  • Subconjunctival

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2022-06-10.